CARDINAL HEALTH P400 PREM U/M 16FR CATH SECURE; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
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Model Number P4P16SD |
Device Problem
Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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Event Description
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Customer reports: we had an issue with the foley trays in one of our neuro cases yesterday.Four out of the five lots below had either a hole in the bag or the balloon would deflate.Per additional information provided on (b)(6) 2023, the foley catheter deflated after insertion.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
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Search Alerts/Recalls
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