BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Increase in Pressure (1491)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
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Event Description
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It was reported that a patient who has a 4fr powerpicc solo2 inserted to the right cephalic vein on (b)(6) 2018 for treatment of nec fasc with cloxacillin q4h via cadd infusion pump.As he was nearing completion of therapy he allegedly began to complained of pain with flushing that appeared to ascend the arm from exit site of the picc.His initial picc measurements 46cm trimmed length and 1cm external measurement, which remained the same until the picc was removed.The picc was removed on (b)(6) (not sure of exact date) and at that time the picc seemed to be leaking about 25cm from the hub, but intact afterwards to the tip.The picc had been unblocked with alteplase at one point, and had intermittent high pressure alarms.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and is likely related to the use of the device.One 4 fr powerpicc solo catheter was returned for investigation.Residual use material was present within the catheter.The catheter extended up to the 45 cm depth marker.Catheter damage was observed near a bend in catheter at the 19 cm depth marker.The catheter was flushed with water using a 12 ml syringe and was observed to be occluded.Additional pressure resulted in white residual material leaking from the damaged portion of the catheter.The segment distal to the split was found to be occluded.Microscopic observation of the leak location revealed a circumferential split in the catheter.One side of the split surfaces was rough and granular.The opposite surface was observed to have a smoother surface finish.The characteristics of the split are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported that a patient who has a 4fr powerpicc solo2 inserted to the right cephalic vein on (b)(6) 2018 for treatment of nec fasc with cloxacillin q4h via cadd infusion pump.As he was nearing completion of therapy he allegedly began to complained of pain with flushing that appeared to ascend the arm from exit site of the picc.His initial picc measurements 46cm trimmed length and 1cm external measurement, which remained the same until the picc was removed.The picc was removed on (b)(6)
(not sure of exact date) and at that time the picc seemed to be leaking about 25cm from the hub, but intact afterwards to the tip.The picc had been unblocked with alteplase at one point, and had intermittent high pressure alarms.Picc removed, no ongoing harm.
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