BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG

    MDR report key: 7438434 · Received April 17, 2018

    Report

    Report Number
    1917413-2018-00865
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    November 12, 2016
    Report Date
    April 17, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903637060
    PMA / PMN Number
    K093972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 6194512; MEDICAL DEVICE EXPIRATION DATE: 2018-01-31;  DEVICE MANUFACTURE DATE: 2016-07-12. MEDICAL DEVICE LOT #: 6194513; MEDICAL DEVICE EXPIRATION DATE: 2018-01-31;  DEVICE MANUFACTURE DATE: 2016-07-12. MEDICAL DEVICE LOT #: 6194509; MEDICAL DEVICE EXPIRATION DATE: 2018-01-31; DEVICE MANUFACTURE DATE: 2016-07-12. INVESTIGATION RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT CLOTTING WAS FOUND ON BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG DURING/AFTER USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281476 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. SEE SECTION H.10. 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other