BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 11942339 · Received June 4, 2021

    Report

    Report Number
    9617032-2021-00594
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, 4 RETENTION SAMPLES FROM BD INVENTORY WERE DRAWN WITH HORSE BLOOD, MIXED, AND STOOD FOR 30 MINUTES. THEY WERE THEN CENTRIFUGED AT 1211RCF FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL SAMPLES SEPARATED AS EXPECTED WITH COMPLETE IMPERVIOUS GEL BARRIERS. 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 BASED ON THE REVIEW OF THE PHOTOS. A ROOT CAUSE COULD NOT BE DETERMINED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SST TUBES CENTRIFUGED AT 2200G FOR 10 MINUTES AND GEL REMAINED AT THE BASE OF THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833952 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0240259

    Patients

    Seq Age Sex Outcome Treatment
    1