Model Number 8888145251 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 2017-july-11.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported to covidien on 2017/june/20 that a customer had an issue with a dialysis catheter.The customer states there is a hole in the extension tube.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the tube and connector were covered with dried blood.The tube past the connector had dried blood inside.A visible hole was not identified.Pmv could not perform functional testing due the dried blood blocking the tube.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the dried blood blocking the tube may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer states there is a hole in the extension tube close to the insertion site.The catheter was removed and replaced.
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Search Alerts/Recalls
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