BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 17145101 · Received June 16, 2023

    Report

    Report Number
    9617032-2023-00728
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6 INVESTIGATION SUMMARY MATERIAL #: 365054 LOT/BATCH #: 2192117 BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR IMPROPER ASSEMBLY WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF IMPROPER ASSEMBLY WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE IMPROPER ASSEMBLY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES THAT THERE WAS GEL MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WE HAVE JUST NOTICED THAT WE HAVE A BOX OF BARRICOR TUBES REF 365054 WHICH DOES NOT HAVE A SEPARATOR (CF. PHOTOS) LOT 2192117 EXP 30-11-2023. CAN YOU TELL ME WHAT THE IMPACT IS ON THESE TUBES WHEN THEY ARE REMOVED, AS WE HAVE DISTRIBUTED A NUMBER OF THEM?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458108 BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2192117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown