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: sample analysis, patient severity, 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 damaged catheter is confirmed; however, the exact cause is unknown.One 3 fr single lumen powerpicc sv catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A split was observed in the extension leg tubing of the returned catheter near the luer hub.A microscopic observation revealed the split in the extension tubing was just within the distal end of the luer hub.Additional tearing was observed opposite to as well as adjacent to the large split.The fracture surfaces of the split and additional tearing were observed to be flat but uneven and exhibited cracks/fissures and beach marks, which are suggestive of material fatigue.However, the exact cause of the split observed in the returned sample is unknown.Possible contributing factors include excessive pulling, twisting, and manipulation of the luer connector hub and/or extension leg.Evaluation findings are in section h.11.
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