BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    MDR report key: 8325784 · Received February 11, 2019

    Report

    Report Number
    1917413-2019-00208
    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. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS 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 EXPERIENCED CLOTTING, CAUSING ERRONEOUS RESULTS AND RESULTING A REDRAW ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118983 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. UNKNOWN 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other