Model Number SEY2DEYDCE |
Device Problem
Nonstandard Device (1420)
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Patient Problem
Unspecified Infection (1930)
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Event Date 01/01/1980 |
Event Type
Injury
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Manufacturer Narrative
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The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
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Event Description
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Customer informed cardinal health that they have seen a spike in their infection rates in the or over the last two months.This case used a cardinal health eye pack sey2deydce that contained a level 3 surgical gown.The exact procedure event date was unknown by the customer.The procedure either was performed prior to the hold and recall notice(s) that were provided to customers beginning on 1/12/2020 or thereafter.No sample was available for evaluation and a work order/lot number was not provided for the kit, therefore, we are unable to confirm that the gown in the kit was part of the recall issued by cardinal health.
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Manufacturer Narrative
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Supplemental mdr is being filed based on new information received from the customer following the submission of the initial mdr report submitted on 2/18/2020.Customer confirmed that they had filed the original complaint in error as there was no issue with the level 3 gowns, either gown 9545ncc or gown 90370nba, in the eye pack sey2deydce.
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Search Alerts/Recalls
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