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Model Number 165816 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
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.The device was not returned.
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Event Description
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It was reported that the user experienced catheter blockage, leakage, accidental removal, bacteriuria, pain and symptomatic urinary tract infection when asked about the complications while using foley catheter.No medical intervention was reported.
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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 "drainage lumen designed too small".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." the device was not returned.
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Event Description
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It was reported that the user experienced catheter blockage, leakage, accidental removal, bacteriuria, pain and symptomatic urinary tract infection when asked about the complications while using foley catheter.No medical intervention was reported.
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Search Alerts/Recalls
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