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 cause remains unknown.One radiographic image of a patient was provided for evaluation.The image appears to show the upper left arm region.A dual lumen catheter appears to be inserted within the patient¿s arm.A bend in the catheter tubing appears to be present at approximately the 4 cm from the proximal end.Based on the image provided, possible contributing factors include manipulation of the catheter during use and securement method.The event description also indicates the kink formed after a dressing change which suggest handling of the catheter may be a contributed to the reported issue.Since the catheter appeared to be kinked, the complaint is confirmed but the exact cause of the kink 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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It was reported "radiology placed on 12/14 at 0 cm external, blood return lost and tpa worked on 12/27.Dressing change on 12/28 showed out 1 cm, 12/30 tpa again.1/3 dressing change again and kink found after dressing change.No documentation of how far external picc was on 1/3 dressing change.".
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