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 bent stylet is confirmed but the exact cause remains unknown.One 4 fr groshong catheter was returned for evaluation.The packaging label was also returned.The product information indicated lot: reds4527.Two kinks were present in the stylet and catheter at the 9 cm and 28 cm depth markers.No apparent evidence of use was present within the tubing or on the catheter surface.One photo sample of a groshong catheter was also provided and corresponded with the condition of the returned sample.The condition of the catheter and stylet prior to kit unboxing remains unknown.Based on the photo sample provided possible contributing factors include damage during storage or handling.Since a bend in the stylet and catheter was observed, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
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