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 detachment of the needle cover is inconclusive due to poor sample condition.One photo sample of a powerloc infusion set was provided for evaluation.The infusion set is shown outside of the packaging.The needle cover is off the needle and the safety mechanism is fully activated.The condition of the needle cover and infusion set prior to kit opening is unknown.Since the photo sample appears to show the device after handling and opening, the complaint could not be confirmed and remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
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