The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to activate the safety mechanism is inconclusive due to poor sample condition.One photo sample of a 22 ga x 0.75 in safestep infusion set was returned for investigation.The product packaging was shown with lot: asdvs0125.The infusion set is shown to be within a plastic container.The safety mechanism is not shown to be fully activated but appears to be slightly advanced.The condition and potential issues with the device could not be clearly investigated.Based on the description of the reported event, possible contributing factors include bent needle and excessive adhesive applied during manufacturing.Since the complaint could not be confirmed from the photo sample provided, the complaint is inconclusive.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.
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H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 safety mechanism activation difficulty was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 22ga x 0.75" safestep safety infusion set.The returned product sample was evaluated and the needle was observed to be bent just distal of the non-engaged safety mechansim.The following observations were noted during the sample evaluation: ¿ the needle was bent at the region where the needle extends from the base ¿ microscopic examination of the sample found no supporting evidence of a specific root cause the safety mechanism was successfully engaged; however, resistance was encountered when advancing the metal sleeve over the bent region of the needle.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.
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