Qn# (b)(4).The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter and extension lines revealed no obvious defects or anomalies.The catheter body length measured 214mm, which is within the specifications of 207-227mm per product drawing.The distal extension line outer diameter measured 0.08653", which is within the specifications of 0.084-0.088" per product drawing.The distal extension line inner diameter measured 0.058", which is within the specifications of 0.055-0.059" per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection was performed on the returned catheter to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all extension lines flushed as expected.The extension lines were tested for liquid leakage per amrq-000071 rev.12 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the catheter body or extension lines.A manual tug test confirmed the extension lines were fully secured within their respective hubs.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of an extension line leak could not be confirmed by complaint investigation of the returned sample.The returned catheter showed no visual defects or anomalies, and no leaks were observed during functional testing performed according to bs en iso 10555-1 annex c.The catheter passed all relevant dimensional inspection.Based on the customer report and the sample returned, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
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