Model Number 00884450123515 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during insertion of the catheter during a procedure, the catheter broke into two separate pieces.The physician could not remove the pieces and referred the patient to a surgeon to have the pieces removed.
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Event Description
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The account alleges that during insertion of the catheter during a procedure, the catheter broke into two separate pieces.The physician could not remove the pieces and referred the patient to a surgeon to have the pieces removed.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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