Model Number 00884450009482 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2020 |
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 post-drainage catheter placement within the patient's biliary system, the drainage catheter became damaged at the bend 7 days later and would not continue to drain.The drainage catheter was replaced for this patient.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The device was examined visually.The complaint could not be confirmed.The root cause is attributed to off label use, the device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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Search Alerts/Recalls
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