The device involved in the incident was not returned for evaluation and no photographs of the failure were provided.A thorough investigation of product design, and manufacturing processes was performed by medcomp engineering in conjunction with the device contract manufacturer.Actions will be implemented to minimize this type of occurrence if determined to be required.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.A definitive root cause of the failure could not be determined.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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The extension with the white clamp was heparin locked.The extension with the red clamp was infusing with a carrier solution of normal saline at 2 ml/hour at the time leaking was noted beneath the dressing.When the dressing was taken down and the extension with the red clamp was flushed, leaking was noted from the white lumen.However, the specific location of the leak was not reported.The picc was removed and a peripheral iv was inserted.
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