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Catalog Number DYND11519 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that after being inserted into the patient, the urinary catheter balloon would not inflate.According to the reporting facility, the urinary catheter balloon was not pre-inflated prior to being inserted into the patient.When the reported product issue was identified, the urinary catheter was removed and a new urinary catheter was inserted.No further incident or adverse patient impact was reported to the manufacturer.The urinary catheter involved in this incident was discarded and unavailable to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to remove and replace the urinary catheter, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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Event Description
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It was reported that after being inserted into the patient, the urinary catheter balloon would not inflate.
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Search Alerts/Recalls
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