During night shift, picc line white lumen was leaking at insertion site.During morning dayshift, picc team came to rewire picc line.After removal, when the white lumen is flushed, the line leaks at the point where the insertion site was.Picc rewired and sequestered.
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The 2.6f picc was returned for evaluation.Visual inspection confirms the complaint.The lumen burst beginning at the 3 cm mark continuing ~1cm down the lumen.It was also noted that the lumen appears to have ballooned beginning at the 4 cm mark and continuing down approximately 1 cm.Under magnification the back side of the burst area appears rippled, indicative of having ballooned prior to bursting.The device subassembly is received from an external supplier and is visually and functionally inspected.Incoming inspection includes visual inspection for kinks, holes, gaps, and functional testing for leaks.At the completion of the final manufacture processes, the catheters are 100% leak tested.Catheter lumens with damage, such as holes, ruptures, tears and/or small pinholes will be detected during this test.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) contains the following warnings and precautions: small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Warning: do not flush against resistance.Do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (15.5 psi).Only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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