Model Number 36304 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient used 7 male external catheters and it would not stay on, and also indicated that they never had this issue before, and thought they were too sticky.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient used 7 male external catheters and it would not stay on and also indicated that they never had this issue before and thought they were too sticky.
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Search Alerts/Recalls
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