Model Number MR17012601 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of returned device is in progress.A follow up report will be submitted when the evaluation is complete.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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Event Description
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Vascular access team (vat) was requested to evaluate patient's picc due to report of difficult aspiration and air being aspirated from picc.Vat assessed picc and found that there was no blood return with aspiration, but only air.Unable to identify evidence of fracture; however, unable to flush the line with air in the catheter.
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Manufacturer Narrative
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A 2.6f double lumen vascu-picc was returned for evaluation.The lumen was trimmed at the 19cm mark.A visual examination of the device revealed no obvious abnormalities or defects.A functional exam was performed.The red 21ga lumen aspirated and flushed without resistance or difficulty.No air was noted in the line.The white 23ga lumen could be aspirated and flushed, but with difficulty.No air was noted in the line.No leaks were identified.The reported failure could not be duplicated.A review of the manufacture records showed the device was manufactured according to specification with no non-conformances or abnormalities.No device failure was found.We are unable to determine the cause or factors that may have contributed to this event.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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