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, applicable previous investigation(s), sample analysis, complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed.The product returned for evaluation was 5fr dl powerpicc solo ft catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel or securement device.The returned product sample was evaluated and a split was observed between the 6 and 7cm mark on the catheter shaft.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
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