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 failure was confirmed; however, the root cause was not identified.The complaint of unable to activate safety mechanism was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 20 ga x 0.75 in safestep infusion set.A photo sample of a safestep infusion set was also provided and appeared to correspond to the returned sample.The returned product sample was evaluated and the needle was observed to be bent at the needle shaft.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.A functional test of the safety mechanism found that the safety mechanism would not engage over the needle tip due to the bend within 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) review is not possible; the manufacturing lot number that was provided is invalid.
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