BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 16078224 · Received December 30, 2022

    Report

    Report Number
    1119779-2022-01563
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 8, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221742 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR THIO VIT K HEMIN 5ML (MATERIAL 221742) AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR CONTAMINATION IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221742 AND THERE ARE NO COMPLAINT TRENDS FOR CONTAMINATION IN THE LAST 12 MONTHS. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE BATCH NUMBER WAS NOT PROVIDED. NO PHOTOS OR RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS ISSUE. THIS COMPLAINT CAN NOT BE CONFIRMED BASED ON MATERIAL TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN WERE OPAQUE AND DAMAGED CONSIDERING THE PRODUCT CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT WAS OPAQUE AND DAMAGED, THEY ARE DEEMING THE PRODUCT CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN WERE OPAQUE AND DAMAGED CONSIDERING THE PRODUCT CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT WAS OPAQUE AND DAMAGED, THEY ARE DEEMING THE PRODUCT CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825015 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 UNKNOWN 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown