Model Number V0043610 |
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# (b)(4) and (pcn# (b)(4).
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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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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Search Alerts/Recalls
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