Model Number 119314 |
Device Problems
Partial Blockage (1065); Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2022 |
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.
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Event Description
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It was reported that the foley catheter was placed in the bladder but there was no urine flow from the catheter during the operation.
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Manufacturer Narrative
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The reported event was confirmed manufacturing related.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.A potential root cause for this failure mode could be ¿tooling misalignment".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.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 actual/suspected device was inspected.
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Event Description
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It was reported that the foley catheter was placed in the bladder but there was no urine flow from the catheter during the operation.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.No root cause is provided as the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was unconfirmed a labeling review was not required.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 the foley catheter was placed in the bladder but there was no urine flow from the catheter during the operation.
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Search Alerts/Recalls
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