URGENT - FIELD SAFETY NOTICE

Transcription

1 URGENT - FIELD SAFETY NOTICE Arrow International c/o Teleflex Medical IDA Business & Technology Park Dublin Road, Athlone Co. Westmeath, Ireland 10 th April 2017 Commercial Name of Affected Product: ARROW Kits with BD Eclipse Needles Type of action: Advisory Notice Arrow Reference: EIF Product code/lott number Refer to Appendix 2 Dear Customer, Details of affected devices Arrow International has received an Urgent Product Advisory Notice from Becton-Dickinson (BD) for their Eclipse Needles. Arrow International purchased these Eclipse Needles from BD and packaged them with certain Arrow products. Refer to Appendix 2 for list of affected product codes and lot numbers. Description of the problem According to the BD letter, a copy of which is attached, Becton-Dickinson (BD) has received reports of safety cover disengagement and needlestick injury (NSI) for the BD Eclipse Needle. Based on customer reports, in some cases when the safety cover is pushed over the needle it disengages, resulting in an exposed needle which can increase the risk of NSI. Some customer reports indicate an audible click sound before the safety cover is locked (activated) followed by a second click sound when the safety cover is locked over the needle. This may potentially increase the risk of NSI if the user assumes the safety cover is locked after the initial click. FIELD SAFETY CORRECTIVE ACTION INSTRUCTIONS ADVICE ON ACTION TO BE TAKEN BY MEDICAL STAFF Our records indicate your facility has received product in scope of this field safety notice. Note this is an advisory notice only. You may continue to use the finished goods containing this needle that you have in stock and will continue to receive. Arrow International are notifying customers to take the following actions: 1. Please provide this field safety notice to all users of the Arrow products listed in the attachment, containing the BD Eclipse Needle, within your organisation and place a copy with affected product. Please consider, clinicians, risk managers, supply chain/distribution centres, etc. in the circulation of this notice. 2. When using the BD Eclipse Needle, follow the instructions for use (IFU) to Centre your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it lock. Per Figure 1, visually confirm the needle is covered when pushing the safety cover over the needle. 1

2 Figure 1: Examples of visual confirmation of un-locked and locked BD Eclipse Needle. 3. Complete the enclosed Acknowledgement Form and fax or it to the below Customer Service contact details. This will allow us to document your receipt of this letter. You need not follow the instructions in the attached BD letter regarding completion of BD s Business Response Card. Instead, complete and return the Arrow Acknowledgement Form and as instructed here. INSTRUCTION FOR DISTRIBUTORS OF AFFECTED PRODUCT If you are a distributor, provide this field safety notice to all of your customers who have received product in scope of this Field Action. There is no further action required. Please be aware that all European Economic Area/Switzerland (EEA/CH) and Turkey Member State Competent Authorities in which Arrow International distribute directly will be notified by Arrow. If you are a distributor and/or have a reporting responsibility within or outside the EEA/CH/TK area, please notify your local Competent Authority of this action. Please forward the notification and all communication with your local competent authority to Arrow International. Arrow International Arrow informs all customers, employees of Arrow and distributors on this Field Action. Transmission of this Field Safety Notice This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please consider end users, clinicians, risk managers, supply chain/distribution centres etc. in the circulation of this notice. Maintain awareness of this notice until all required actions have been completed in your organisation. Contact reference person Should you require any further information or support concerning this issue, please contact: Customer Service Contact: Shane Kenny Telephone: +353 (0) FAX: +353(0) Recalls.intl@teleflex.com Arrow International is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service. For and on behalf of Arrow International, Padraig Hegarty Padraig Hegarty VP, QA 2

3 Appendix 1 FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT FORM Customer No. PRODUCT FIELD ACTION BY TELEFLEX - IMMEDIATE ATTENTION REQUIRED Ref. EIF ARROW Kits with BD Eclipse Needles RETURN COMPLETED FORM IMMEDIATELY TO: FAX : +353 (0) Recalls.intl@teleflex.com We confirm receipt of this FSN and acknowledge that we have read and understood the Urgent Medical Device Notification for ARROW Kits with BD Eclipse Needles. COMMERCIAL NAME OF AFFECTED PRODUCTS: ARROW Kits with BD Eclipse Needles Complete this Acknowledgement form and return immediately by using the fax number or address above. INSTITUTION NAME (EG NAME OF HOSPITAL, HEALTH CARE ORGANISATION) INSTITUTION ADDRESS Phone / Fax FORM COMPLETED BY: Stamp PRINT NAME: SIGNATURE: DATE 3

4 Appendix 2 - EIF Product Code ASK DU10 Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch 23F15L F16J F16B F16H F16B F16A F16L F16D F16H F16C0113 ASK ST 23F16B F17B F16F0011 ASK PRJ 13F16L F16C F16C F15K F16F F16M F16D F16C F15L F15G F17A F16D F16J0105 ASK MUSC 23F15M F15K0031 ASK PHF1 23F15H F16E F16K F16A F16A F16C F16E0176 ASK ST CA P1A ASK DU4S 23F15K F16B F16C0022 ASK PHF2 23F16F F16F F15K F16C F16E F16H F16G0047 ASK DU4S1 23F15M F16D F16G F15L F16G F16H F16F F15H F15M F16H F15J F16A F15H F16A F16M0047 ASK DU5S 23F15K F16C0022 ASK PRJ 13F16A F16C F17B0152 ASK PST1 23F15L F16D F16G F16F F17C0057 ASK AH ASK DU5S1 23F15M F16G F17B F16G F16A0037 CA P1A 23F16L F16K F16C F16H F16K0302 ASK PRJ ASK DU7 23F15K F16M F17B F16H F15H0195 ASK DU8 23F15K F16B F15H F16B F15K F15L F16D F15J0493 ASK PRJ 13F16H F15K F16A0300 ASK BGH 23F16F F15K F16J F15L F16B F16H0477 ASK PST 23F15L0772 ASK SPH 23F16G F16A F16B F17B F15M F16L F16C0008 ASK DU9 23F16J F16A F16C F16M0173 CA P1A 13F16D F16K F16B F16E F15H F16E F16K F16C F16F F15J F16H F16K F16D0252 ASK HF2 23F15L F15K F17A F16L0181 ASK HFH2 23F16E F16A F15L F17B F16K F16G F16C F15M F16B F15L F16H0831 ASK HF3 23F16F F15M F16C0505 ASK AH 23F15M F16K F16J F16B0076 CA P1A 13F16C0116 ASK HCA 23F16A F17A F16K F16B F16C0116 CA P1A 23F16E F16J F16B F16C F15H F16G F16J0243 ASK MM 23F16E F16D F15H F15J F16K F16H F16E F15M F15K F16M F16K F16E1075 CDA A 13F16A F15L F15H F16H F16F F16D0187 ASK CA ASK ST 23F16A F15J F16M F16G F16L F16D0372 ASK HF-S 23F15K F15M0909 ASK PHHM1 23F15J F16L F16E F15L F16C F16H F15M F16F F15M F16D F15H F16A0372 ASK MM 13F17A F15M F16E F15J F16C F15K F16B F16H F15K0028 CDA U1A 23F16D F15L F16B F16J F16B F16H F15M F16D F15H0270 ASK PRJ 13F16D F16M F16A F16F F15L F16F F16B F16A F16A F15L F16F F16C F16C F16C F15L F16M0019 CDA A 13F16A0219 ASK MHT 23F16D F16E F15M F17B F15H0203 ASK MM3 23F16E F16G F16A0100 ASK PST 23F16B F15J F16F F16H0805 ASK PRJ 13F16A0235 ASK AH 23F16A F15L F16G F17A F16B F15H F15M F16H F15G F16D F15H0250 CDA A 13F16A F16J F15G F16D F15L F16A0145 CA P1A 23F16K0287 ASK ST 13F15H F16E F16A F16B F16K F15H F16F F16A F16B F16M F15M F16F F16B F16C0042

5 Appendix 2 - EIF Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch CDA A CDA A CDA P1A CDA P1A CDA P1A CDA HPK1A CDA HPK1A CDA HPK1A CDA HPK1A CDA HPK1A 13F16D F16K0306 CH H 71F16L F16D F16D F16D F16L F16D F16E F16E F16E F17A F16F F16E F16F F16F0023 CDA P1A 13F17B F16H F16F F16F F16F F15J0140 CH H 71F16H F16G F16H0772 DE-24701S-AG1 13F16G F15J F16K F16H0677 DE-25703S-AG1 71F16H F16M F16J F16L F16J F16H F15H F16A F17A F16K F16J0565 CDA P1A 13F15K F16D F16B F17B F16J F15K F15M F16C F17B F16M F16A F17B F16D F16C F17A2345 CDA P1A 13F16B F15H F16F F16D F16C F16C F16H F16G F16E F16D F16D F16B0062 DE BGH 71F16J F16E F16D1711 CDC JX1A 13F16D F16J F16J F16F F16E F16F F15K F16K0478 DE-24701S-AGK 71F16F F16F0266 CDC JX1A 13F16F F16H F16K F16G F16H F16J0016 CDC JX1A 23F15J F16M F16J1780 DE-25703S-AGK 71F16H F16L F16G F17A F16J F16J0365 CDC JX1A 13F17A F16K F16E F16K F16J F17A F16D F16H F17B F16K1581 CDC JX1A DE-04701S-AGK 13F15H F16J F16J F16L F16L1108 DE-24703S-AGK 13F15H F16A F16K F17A F16M F16A F16B F16D F16B F17B F16D0087 CDC JX1A 23F16C F16E F16C0559 DE-25855S-AGK 71F17A F16F F16F F16G F16C F16M0165 DE DK 13F16K F16K F16J F16D F17B F16L0285 CDC JX1A 23F16F0313 DE-04730S-AGK 71F16L F16E F15L0004 EU HPMSB 13F16A F15K F16M F16F F16K0297 CDC JX1A 13F16A F16E F16H F16G F15H0325 EU HPMSB 13F16L0071 CDC JX1A 23F16B F16K F16G F15K F16M0048 CDC JX1A 23F16D F17A F16H F15M F16H F16D0112 DE-14955S-AGK 71F16L F16H F16B0076 EU HPMSB 23F16L F16E F16D F16J F16H F17B F16F F16D1189 DE KBR 71F16J F17B F16H0967 CH H 71F16H F16E F16J F15H F16L F16J F16E F16K F15J F16L F16L F16F F16K F16B F16H F17B F16G F16L F16C F16L F16D F16H F16M1117 EU HPMSB 13F16E0036 CH KM 23F16H F16J F16H F17A F16E F16L0736 CH KM 71F16D F16J F17A F16J0124 DE-15703S-AGK 23F16M F16B F16J F17B F17B0123 CDA HPK1A 23F16L F16B F16J F17B S15D1420 CDA HPK1A 23F16M F16B F16K F17C0469 EU HPMSB 13F16B F15H F16D F16L F17C F15K F15K F16E F16M F16B F15K1002 CDA P1A 13F15L F16E F17A F16C F15K1644 CH H 13F16A F16H F17A F16D F16B F16A F16H F17B F16D F16C F16A F16H F17C0503 DE KVI 71F16H F16C0861 EU HPMSB 13F16B F16M F16B F16H F16D0378 CDA P1A 13F16C F17A F16C F16J F16E F16C F17A1802 DE BGH 71F16H F16M F16E F16D F16C F16L F17A F16E F16G0238 CH H 71F16E F17C F16C F16F1940 DE-25703S-AG1 13F16H F16F0387 DE-24701S-AG1 71F16C F16D F16G1341

6 Appendix 2 - EIF Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch Product Code Lot/Batch EU HPMSB EU HPMSB EU HPMSB EU HPMSB EU HPMSB EU HPMSB EU HPMSB 71F16J F16E F16K F15K F16E F16J F16H F16M F15K F16H1320 IB GUC UK THT 71F16J F16J F17A F15L F16K1913 EU HPMSB 71F16L F16J F17C F15M F17A F16M F16K F16B F16A F16C F17B F16K F16D F16B F16C F15K F16E F16F F16C F16D1165 UK MSB 71F16C F16J F16F F16E F16E F16C F16K F16G F16F F16M0466 EU HPMSB IB HLP UK MID 71F16D F16K F16J F16F F17A F16E F16K F16K F16H F16B F16E F17A F16L F16J F16E F16J F16D F16M F16J F16F1899 UK RDE1 71F16J1801 EU HPMSB 71F16F F17B F16M F16J F16K F16K F16B F17A F16K F16M F15L F16B F17A F17A F17A F16A F16C F17B F16B F16B F16B F16E F17C F16E F16D F16B1424 IB HRH 71F16E F15L0264 UK MSB 71F16K F16K F16B F16H F16B F16K F15K F16C F16M F16B F16M F15K F16E F17A F16D F16D0168 UK RDE1 71F16B1500 EU MSB 71F16F F17C F16E F16E F16C F16H F16C F16J F16F F16E F16H F16C F16L1737 UK MSB 71F16F F16E F16J F16E F17A F16K F16F F16M F16F F15K F16M F16G F17A F16F F16E F17A2333 UK THT 71F16H F17A1810 IB GUQ 71F16G F16L F16B F16J F17B F16J F17A F16D F16J F16C F16L F16D F16G F16J F16C F16L F16E F16G1343 UK RDE1 71F16J2215 EU MSB 71F16E F17B F16J F16J F16M F16F F17B F16L F16K F17B F16L F16C F15K0928 UK MSB 71F16L F15K F15L F16F F15K F16L F15K F16A F16G F16B F16L2107 IB HRH 71F16B F16C F16K F16C F16M F16C F16F F17A F16E F17A0854 EU MSB UK MSB 71F16C F16K F17A F16G F17B F16D F16L1673 IE MRC 71F16L F16J F17C F16E F17A F16C F16J F16C F16E F17A F16D F16M F16E1175 UK ANHS 71F16F F16D F16E F17B F16F F16J F16F F16F F16C F16G F16J F16L F16J F16E F16C1862 GR FMSB 71F16K F16D F16K F16E F16D0984 NL SLZ UK ANHS 71F16K F16H F16L F16F F16F F16L F16L F16M F16J F16F F16M1428 GR UFMSB 71F16J F16M F16J F16C1749 UK ANHS 71F17A0305 GR MSB 71F16M F17A2038 UK RDE1 71F16K F16F F17A1833 GR MSB 71F16K F17B F16L F16M F16D F16E F17C F16L F16B F16E F16E1688 TI MSB 71F17A F16M F16D F16K F16F F16B F17A F16E1655 IB GUC 71F15K F16G F17A F17A F16F0487 UK MID 71F16B F16H F17A F17C F16G1298 UK MSB 71F16C F16J F17C0039 UK THT 71F15K F16G F16K F16K F16L F16L F17B1274

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