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 but the exact cause remains unknown.The product returned for evaluation was a one 20ga x 0.75"safestep safety infsuion set.The returned product sample was evaluated and the needle was observed to be bent near the exit site from the non-engaged safety mechanism.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The needle tip was barbed suggesting contact between the needle and port base.The safety mechanism was successfully engaged; however, resistance was encountered when advancing the safety mechanism over the bent region of the needle shaft.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, as no manufacturing lot number has been provided by the complainant.
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