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 04/27/2022 |
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 inside of the foley statlocks appeared to have sharp teeth that were damaging the catheter integrity and customer noticed tiny holes in the catheter.The user monitored it to see if it would spike right through the silicone catheter.It was stated that customer had been trimming the teeth like structures off (lot #jufz2074, lot #jufz2077).
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Manufacturer Narrative
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The reported event is inconclusive the statlock does not cause any damage to the catheter when it is placed within in device.Visual evaluation noted 1 statlock stabilization device was received with original open packaging.Placed in house foley catheter within statlock.Although an exact root cause could not be determined a potential root cause could be clamp spikes too long.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because labeling could not have prevented the reported issue.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 evaluated.
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Event Description
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It was reported that inside of the foley statlocks appeared to have sharp teeth that were damaging the catheter integrity and customer noticed tiny holes in the catheter.The user monitored it to see if it would spike right through the silicone catheter.It was stated that customer had been trimming the teeth like structures off (lot #jufz2074, lot #jufz2077).
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Search Alerts/Recalls
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