BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE

    MDR report key: 12493288 · Received September 18, 2021

    Report

    Report Number
    9617032-2021-00980
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    August 20, 2021
    Report Date
    August 25, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE FURTHER EVALUATED: 4 RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE DRAWN WITH HORSE BLOOD, MIXED, AND STOOD FOR 30 MINUTES. THEY WERE THEN CENTRIFUGED AT 1850G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL SAMPLES SEPARATED AS EXPECTED. 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 POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 TUBE PMS PLH 13X75 3.0 SLBL LIM CE, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE MECHANICAL SEPARATOR DOESN'T MOVE DURING CENTRIFUGATION. ABOUT TWO TUBES PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390836 BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1158504

    Patients

    Seq Age Sex Outcome Treatment
    1