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Catalog Number DYND140216H |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/09/2024 |
Event Type
Injury
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Manufacturer Narrative
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According to the customer on (b)(6) 2024 the catheter balloon ruptured inside the patient requiring the foley catheter to be replaced.Per the customer they used 8ml's to inflate the balloon, and they believed the balloon to be structurally intact prior to placement.Per the customer they are reported to be "fine".The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Event Description
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According to the customer on (b)(6) 2024 the catheter balloon ruptured inside the patient requiring the foley catheter to be replaced.
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Search Alerts/Recalls
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