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Model Number 11823 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause for the alleged issue was not able to be determined.Internal complaint number: (b)(4).
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Event Description
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Patient tracking received a tracking form through email reporting a catheter revision.Additional follow-up with the agent covering the issue via phone call confirmed that the patient had been scheduled for a revision as their pump was flipped.Per the agent, "when we got in, the catheter was also not patent.It wasn't kinked, it just had no flow." agent reported that it was not known why the pump flipped and confirmed that the pump had been sutured down initially.The sutures were reportedly still visible.The pump remains implanted, and the catheter will not be returned.Per the agent, "we trimmed off as much as we could, but the rest was scarred in place." this mdr will capture the alleged catheter issue.The pump flipping issue will be captured in mdr 3010079947-2023-00014.
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Search Alerts/Recalls
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