Catalog Number 165816 |
Device Problems
Burst Container or Vessel (1074); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that foley "balloon" in the foley tray was found defective.
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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.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
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Manufacturer Narrative
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Per additional information received, bd has determined that this mdr event is not reportable.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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Event Description
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It was reported that foley balloon in the foley tray was found defective.Per additional information received via liberator on (b)(6)2024, it was reported that no other issues had been reported.No patients were affected or harmed by the defective catheters.
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Search Alerts/Recalls
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