Catalog Number 5000-01-02 |
Device Problem
Component Missing (2306)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 fluid delivery line was not attached in the arctic sun device which was returned to the hospital after repair.They did not know if it was returned to them without it or whether it was lost in the hospital.
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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 bard represents all of 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 bard.
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Event Description
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It was reported that the fluid delivery line was not attached in the arctic sun device which was returned to the hospital after repair.They did not know if it was returned to them without it or whether it was lost in the hospital.
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Search Alerts/Recalls
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