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 a foreign matter on the device is inconclusive due to poor sample condition.One photo sample of a guidewire wire being held was provided for evaluation.The guidewire was observed to contain a curve near the distal end.A darkened spot on the guidewire appeared to be present; however, it could not be clearly determined if the dark spot was discoloration or a residual material.The open kit and catheter contents are visible in the background.The lack of a returned sample did not allow for an inspection of the discolored region; therefore, the source and type of material could not be identified.Based on the information provided, possible contributing factors include contamination of kit component during handling or use.A review of the manufacturing records did not reveal any evidence to suggest that a manufacturing related root cause contributed to the reported event.The condition of the component prior to kit opening and handling is also unable to be determined; therefore, the complaint could not be confirmed and remains inconclusive at this time.
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