The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of bent accucath needles was confirmed; however, the root cause was not identified.The product returned for evaluation was two 20ga x 2.25¿ accucath ace peripheral iv catheter assemblies.The first sample (sample 1) was received without the catheter.The second sample (sample 2) was received with the catheter overlaying the needle shaft.Both samples exhibited bends in the needle shafts at the exit sites from the carriers.Both safety buttons were depressed and both needles were partially withdrawn into the housings.The needle bends prevented wire mobility, which prevented full needle withdrawal into the housings.Microscopic inspection of the needle tips and wire coils was unremarkable.Bends were observed in both needle shafts, preventing activation of both safety mechanism; however, no evidence was discovered that informed the cause of those bends.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include device manipulation prior to or during attempted use.A lot history review (lhr) of reeq0703 showed three other similar product complaint(s) from this lot number.
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