Field Safety Notice Teleflex Arrow® Kits and Sets with Introducer Needles Multiple Products (ICN 1628)
Important Customer Notice Field Safety Notice
Ref: 2022/1628 ICN Number: 1628
- Teleflex has issued an Advisory Field Safety Notice for Arrow® Kits and Sets with Introducer Needles.
- Teleflex has received complaints reporting that the introducer needle hub in some Arrow® kits crack under stress during the catheterization procedure.
- Teleflex has identified four clinical practices (as noted on page one in the Field Safety Notice), that combined with a lack of adequate drying time, may overexpose the needle hub to alcohol-based antiseptic solutions such as Chlorhexidine based antiseptic / octenidine solution.
- If the needle hub is saturated with an antiseptic solution it may weaken.
- A weakened needle hub combined with the standard insertion method which requires pressure to be placed on the needle may result in a cracked needle hub.
- If a cracked needle hub is not detected prior to use, the clinician may experience false signs of a possible insertion related pneumothorax. In addition, the clinician may not be able to aspirate a flashback of blood during needle introduction.
- There are 150 affected products available, or previously available, from NHS Supply Chain.
- Please see our Downloads ▼ section to refer to the attached Product Listing and Field Safety Notice for information on the products affected.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Teleflex does not recommend use of an alcohol-based antiseptic solution in place of an approved ultrasound gel for invasive procedures.
- Additionally, Teleflex advises following good clinical practice for skin antisepsis, which includes sufficient dry time (i.e., three minutes or more) for the skin antisepsis prior to needle insertion.
- Complete the Acknowledgement Form (found on page three of the notice) and return the form to email@example.com.
- If you have any clinical education or product support questions, please direct these to Clinical.firstname.lastname@example.org .
If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.