Flash Back Function - During the insertion of the cannula, blood flow is visualized by blood flash back in the hub of the cannula.

Transcription

1 BD Medical The Danby Building Edmund Halley Road Oxford Science Park Oxford, Oxfordshire, OX4 4DQ tel: +44 (0) fax: +44(0) TECHNICAL DATA SHEET BD Venflon Pro Safety IV catheter, Sterile 1. General Information 1.1 General The Venflon Pro Safety Needle Protected I.V. Cannula with polyurethane catheter and injection port is a singleuse disposable device in the Becton Dickinson Infusion Therapy AB range of peripheral I.V. Catheters. The product is designed to access the peripheral veins of the patient s blood system for re-hydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes. A special product feature is the needle tip protection device, which is activated when the steel needle is withdrawn. It covers the steel needle tip and protect against accidental needle stick. Flash Back Function - During the insertion of the cannula, blood flow is visualized by blood flash back in the hub of the cannula. Catheter Dwell Time- BD does not specify a minimum or maximum in situ dwell time for this catheter family. Catheter dwell times must be dictated by healthcare organization procedures, national clinical guidelines, each clinical environment and the clinical status of each patient. The content of this Technical data sheet can be changed without further notice. This document is electronically approved Page 1 of 6

2 REF GAUGE SIZE (MM) Flow Rate ML/MIN COLOUR x BLUE x PINK x GREEN x GREEN x WHITE x GREY x ORANGE x BLUE x PINK x GREEN x GREEN x WHITE x GREY x ORANGE x BLUE x PINK x GREEN x GREEN x WHITE x GREY x ORANGE 1.2 Certification BD PRODUCT Venflon TM Pro Safety BD MANUFACTURER Becton Dickinson Infusion Therapy AB Florettgatan 29C, PO Box 631, SE Helsingborg, Sweden ISO CERTIFICATION ISO 13485:2003, EN ISO 13485:2012 Certificate No CE MARKING CE Certifícate Medical Devices Directive 93/42/EEC - Annex II Certificate No BD MANUFACTURING SITE Becton Dickinson Medical (S) Pte Ltd 30 Tuas Avenue 2, Singapore , Singapore Page 2 of 6

3 1.3 Material Component Material Cannula hub Catheter Polyurethane Bushing Polyetherimide + white Needle hub Cannula Stainless Steel AISI 304 (Carbon Max 0.08 %, Silicon Max 1.00 %, Manganese Max 2.00 %, Phosphorus Max %, Sulphur Max %, Nickel %, Chromium %, Fe %) Flow control plug Needle cap V-clip Stainless steel V-clip cover + colourant Foil Polyester Plug + colourant Protection cap Valve Methyl vinyl Polysiloxane Silicone solution 20 cst Medical Grade Silicone Silicone solution 100 cst Medical Grade Silicone Silicone solution cst Medical Grade Silicone Silicone solution cst Medical Grade Silicone 1.4 Material of concern Materials of concern are chemicals or substances that have been identified as having the potential to cause long term effects on humans or the environment. MATERIAL COMMENT DEHP/Phthalates The products do not contain phthalates Latex The products do not contain latex. Bisphenol A The products do not contain bisphenol A. Substances of animal origin BSE/TSE Polyvinyl chloride (PVC) These devices utilize very small amounts of tallow or tallow derivatives (e.g. stearates in polymers). Per MEDDEV 2.4/1 Rev. 9 June 2010 and MEDDEV 2.11/1 Rev 2 January 2008, such substances are not considered as derivatives of animal tissues for the purpose of this rule which therefore does not apply. The products do not contain polyvinyl chloride 1.5 REACH information Based on information available and BD s continuous data collection efforts throughout the supply chain, BD have not identified any chemicals in the articles and packaging with the Product Numbers as referenced above, in an individual concentration above 0.1% weight by weight (w/w), which have been listed as SVHC and included in the "Candidate List" published by the European Chemical Agency (ECHA) on 28 October 2008, according to Art. 59 (1, 10) of the Regulation (EC) N 1907/2006 (REACH). The substances published in such list are candidates for eventual inclusion in the List of Substances Subject to Authorization (Annex XIV of REACH). 1.6 Biocompatibility BD Medical products comply with the requirements of the standard for biocompatibility of medical devices, ISO Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. 1.7 Sterilization Sterilization method: Radiation (EN ISO Sterilization for Healthcare products- Radiation Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices). Page 3 of 6

4 1.8 Shelf life Shelf life 3 years Store in dry and warm place and not exposed to strong light. 1.9 Standards Standard EN ISO :2009 EN ISO :1996 ISO 594-1:1986 ISO 594-2: 1998 EN ISO :2009 EN ISO 11607:2006 EN 980:2008 EN 1041:2008 EN ISO :2006 EN ISO 13485:2012 EN ISO 14971:2012 ISO14644:1999 Title Sterile, single use intravascular catheters General Requirements Sterile, single use intravascular catheters Over needle peripheral catheters Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment General Requirements Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment Lock Fittings Biological evaluation of medical devices Packaging for terminally sterilized medical devices Symbols for use in the labeling of medical devices Information supplied by the manufacturer of medical devices Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices Medical devices. Quality management systems. Requirements for regulatory purposes Medical devices Application of risk management to medical devices Clean room standards 1.10 Classification Class IIa Medical Device under Rule 7, Annex IX of Medical Devices Directive 93/42/EEC as amended GMDN code GMDN code Peripheral IV Catheter 1.12 Good Manufacturing practices The entire manufacturing and testing processes are following the Good Manufacturing Practices as specified below Incoming raw materials are verified via material inspection and testing and our suppliers are approved via our vendor management system. In addition to the automatic on-line inspections, in-process inspections are performed in addition to final product testing to ensure compliance with approved specifications. The manufacturing and testing details of each batch of product are recorded on a batch record which is retained in accordance with our document control procedures BD operates a system of Internal and external audits to maintain compliance BD confirms that it will continue to adhere to relevant international standards in designing and manufacturing its products. BD reserves the right to use the internal change control procedure to change raw material suppliers and production process 1.13 Others Material Data Safety sheets are not required for this product Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 of January 14th, 2011 concerning materials and plastic objects intended to get in touch with foodstuffs) is not required as BD products are used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin. Page 4 of 6

5 2. Packaging 2.1 Packaging Characteristics The product is packed in a plastic blister bubble, sealed with a top web lid, on which company, product, lot, sterilization and expiry date details are printed. Unit pack Quantity 1 Dimensions 152mm x 35mm Shelf box Quantity 50 Dimensions173mm x 164mm x 134mm 2.2 Labelling Languages Item Language ISO Code 1 Bulgarian bg 2 Croatian hr 3 Czech cs 4 Danish da 5 Dutch nl 6 English en 7 Estonian et 8 Finnish fi 9 French fr 10 German de 11 Greek el 12 Hungarian hu 13 Italian it 14 Kazakh kk 15 Latvian lv 16 Lithuanian lt 17 Norwegian no 18 Polish pl 19 Portuguese pt 20 Romanian ro 21 Russian ru 22 Slovak sk 23 Slovenian sl 24 Spanish es 25 Swedish sv 26 Turkish tr 27 Ukrainian uk Page 5 of 6

6 2.3 Example labelling Unit pack, catalogue number Extract from Shelf box (F1924) end of document Page 6 of 6