BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8325883 · Received February 11, 2019

    Report

    Report Number
    1917413-2019-00210
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 29, 2019
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE AND/OR PHOTOS FROM THE CUSTOMER FACILITY. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE LOT NUMBER IS UNKNOWN. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE COULD BE DETERMINED AS THE LOT NUMBER IS UNKNOWN. RATIONALE: THE INVESTIGATION COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THERE WERE NO SAMPLES AND/OR PHOTOS SUBMITTED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG EXPERIENCED CLOTTING CAUSING ERRONEOUS RESULTS AND REQUIRING A REDRAW ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121820 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. UNKNOWN 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other