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, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed, but the exact cause could not be determined.One 4fr groshong single-lumen picc was returned for investigation.The catheter was received in two segments.A tactual investigation revealed no significant elastic weakness in the tubing.The distal segment was 41cm in length.The proximal segment of tubing was attached and secured to the two-piece connector.The adjoining ends of the catheter were located between the 40 and 41 cm depth marks.A microscopic examination of the adjoining ends of the catheter revealed that the contours did not match.When the depth marks were positioned against a ruler, it appears that approximately 1mm of tubing was missing.The adjoining ends of the catheter were uneven and granular.A silvery material was observed on the tubing at the adjoining ends of the catheter.A hole was observed in the tubing at the 19cm depth mark.The same silvery material was observed at the 19cm depth mark.Material had been removed from the catheter at the hole and from the external surface of the tubing around the hole.Had the hole existed at the time the catheter was flushed prior to placement, a leak would have been obvious.A functional test revealed no leaks in the catheter, except at the hole, which was located at the 19cm depth mark.The leak in the tubing could be associated with the reported pain; however, the cause of the leak and break in the tubing could not be determined.No damage associated with the manufacturing process was observed on the returned sample.H3 other text: evaluation findings are in section h.11.
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