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 break in the catheter was confirmed but the cause is unknown.A photo of a proximal section of a 4fr s/l groshong nxt catheter was returned for evaluation of this complaint.The catheter contained the proximal connector (luer adaptor, extension leg and molded suture hub) and the distal connector.None of the catheter shaft was visible in the picture.It is unknown if the catheter shaft dislodged from the two-piece connector or if the tubing broke within the two-piece connector but is not visible in the photo.Without the physical sample, the exact location of the failure could not be established, and the microscopic and dimensional analysis could not be conducted.Therefore, the exact root cause could not be determined at this time.Based on the description of the reported event and evaluation of the photo, possible contributing factors include misassembled or improper connection, tensile (pulling) forces, over-pressurization or material fatigue.
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