Model Number V0070740 |
Device Problem
Inadequate Instructions for Healthcare Professional (1319)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
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 evacuator bulb suctioning for the wound received six wrong labels.Stated that six 400ml evacuator received them as a wrong label.The affected evacuators were (pcn# v0070740) and (pcn# v0043610).
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Event Description
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It was reported that the evacuator bulb suctioning for the wound received six wrong labels.Stated that six 400ml evacuator received them as a wrong label.The affected evacuators were (pcn# v0070740) and (pcn# v0043610).Per customer response received via mail on 01nov2022, it was stated that the bard was incorrectly labeled for v0043610 cws 400 closed wound suction kits.The wrong label said it was v0070740 -100cc silicone closed wound suction evacuator w/reflux valve.
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Manufacturer Narrative
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The reported event was confirmed as manufacturing related.A potential root cause for this event could be, "incorrect line clearance".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.
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Search Alerts/Recalls
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