It was reported by healthcare professional the nurse attempted to access the port with powerloc max needle.Once the needle touched the silicon part, it immediately bent.The nurse had to remove the needle immediately and replaced it with a new needle without complication.Additional information provided: there was no medical intervention, intubation, or unusual circumstances.The device was not re-sterilized or re-processed.Device was not tested prior to use.An additional device was required.(b)(6) 2023 - the returned sample exhibited a bent needle.
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The following were reviewed as part of this investigation: patient severity, complaint and batch history, sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent needle was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 22 ga x 0.75 in powerloc max infusion set.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 sample appeared free of obvious use residue.The tip of the needle bevel appeared unremarkable.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass 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 batch history review (bhr) of asfvf029 showed no other similar product complaint(s) from this lot number.
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