Model Number A319414AM |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2023 |
Event Type
malfunction
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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.H11: section a through f - the information provided by bd represents all 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 bd.
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Event Description
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It was reported that when the nurse was in the process of insertion, they noticed that the foley was severely adhered to the drain tubing.When it was peeled off of each other, the foley catheter had some holes on it.
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Manufacturer Narrative
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The reported event was confirmed manufacturing related.Although an exact root cause could not be determined a potential root cause could be insufficient package design that does not protect the product from elements during shipping and storage.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review was not required as labelling would not have prevented the reported event.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 actual/suspected device was inspected.
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Event Description
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It was reported that when the nurse was in the process of insertion, they noticed that the foley was severely adhered to the drain tubing.When it was peeled off of each other, the foley catheter had some holes on it.
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Search Alerts/Recalls
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