BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PRODUCT-PR

    MDR report key: 21645151 · Received March 19, 2025

    Report

    Report Number
    1423537-2025-00130
    Event Type
    Death
    Date Received
    March 19, 2025
    Report Date
    March 19, 2025
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE FNJ WAS USED ON THIS REPORT DUE TO A SYSTEM REQUIREMENT FOR USE OF A PRODUCT CODE. HOWEVER, THE TRUE PRODUCT CODE COULD NOT BE DETERMINED AS THERE WAS NO PRODUCT INFORMATION RECEIVED WITH THE COMPLAINT. A NON-CONFORMANCE REVIEW COULD NOT BE PERFORMED BECAUSE NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO DEVICES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    PLAINTIFF (B)(6) ALLEGES THAT HER HUSBAND, (B)(6), WAS HOSPITALIZED WITH COVID-19 AT (B)(6) ON (B)(6) 2021. WHILE THERE, MR. (B)(6) ALLEGEDLY WAS EXPOSED TO AND INFECTED WITH BURKHOLDERIA CEPACIA BACTERIA FROM CONTAMINATED PRODUCTS, SOME OF WHICH ALLEGEDLY WERE LATER RECALLED DUE TO CONTAMINATION AND RESULTING INFECTIONS AND DEATHS. NO PRODUCTS ARE IDENTIFIED IN THE COMPLAINT. PLAINTIFF ASSERTS A VARIETY OF PRODUCTS LIABILITY CLAIMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453388 UNKNOWN PRODUCT-PR BED, MANUAL FNJ CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death