Catalog Number 0250070620 |
Device Problem
Material Separation (1562)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
Injury
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Event Description
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It was reported that piece of the membrane from the nacl bag went inside the patient and another operation was performed.The broken piece was successfully retrieved.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: bag's membrane landed in the tube inside the patient.Probable root cause: material/design error; manufacturing/assembly/ service error; excessive user force; severe shipping conditions; disposable tip rubbing against product; user error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
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Event Description
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It was reported that piece of the membrane from the nacl bag went inside the patient and another operation was performed.The broken piece was successfully retrieved.
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Search Alerts/Recalls
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