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 damaged packaging is confirmed but the exact cause remains unknown.Two 20 ga x 1 in miniloc infusion sets were returned within sealed packaging.Both infusion sets were observed to have damage damaged packaging at the center of the clear film.The clear base tabs were found to be protruding through the clear packaging.One sample was found to have a partially fractured tab.The tyvek packaging was found to have wrinkling and a crease which may suggest the packages may have experienced compression.Based on the condition of the returned samples, possible contributing factors include compression damage leading to damage on the packaging and infusion set component.The location at which the damage occurred and source of the damage could not be determined from the information provided and likely occurred outside of bd control; therefore, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
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