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 catheter kink is confirmed but the exact caused remains unknown.Two radiographic images of a catheter within a patient were provided for evaluation.The first photo shows a powerpicc catheter inserted within a patients arm.The catheter appears to twist and kink at two locations on the proximal end of the catheter.The second image appears to show the same catheter; however, only one kink appears to be present.This may suggest manipulation of the catheter during use.Based on the description of the reported event, possible contributing factors include insertion method, securement of catheter, and excessive manipulation of the catheter during use.Since the radiographic image appears to show evidence of a kinked catheter, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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