Model Number FOL0102 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was a design flaw in the foley statlock and this issue has been going on for the patient for a long time.Stated that there was a little post and it snapped on the top part of the product when it pulled from the leg bag it tore a hole in the tube and the content would leak everywhere.
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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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Event Description
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It was reported that there was a design flaw in the foley statlock and this issue has been going on for the patient for a long time.Stated that there was a little post and it snapped on the top part of the product when it pulled from the leg bag it tore a hole in the tube and the content would leak everywhere.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿clamp spikes too long¿.It is unknown whether the device had met relevant 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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Search Alerts/Recalls
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