Device Problems
Component Missing (2306); Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the kit used to change from a suction jackson pratt wound drain to gravity leg bag was no longer going to provide the adapter piece.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "lack of training in applicable drawing".It was unknown whether the device had met specifications.Based on patient code 2645 the product was not used on the patient, but it was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.The device was not returned.
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Event Description
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It was reported that the kit used to change from a suction jackson pratt wound drain to gravity leg bag was no longer going to provide the adapter piece.
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Search Alerts/Recalls
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