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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult removal after safety activation is confirmed but the exact cause remains unknown.Two photo samples of a 19 ga miniloc infusion set were provided for evaluation.The first photo sample shows the infusion set during patient use.The safety mechanism is in its advanced position; however, it is unknown if the safety is fully locked in place.The safety base shown to be on the patient skin.The patients skin appears to be being pulled by the infusion set.The condition of the needle and safety mechanism could not be inspected for a barbed needle or damage to the safety mechanism components.The second image shows the device outside of patient use.The safety mechanism is damage and dis-assembled.The needle shaft and bevel are not shown.Based on the description of the reported event and photo samples provided, possible contributing factors include barbed needle tip caught on skin and damaged safety mechanism components.Since the device could not be clearly inspected, the exact cause remains unknown at this time.H3 other text : evaluation findings are in section h.11.
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