BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7456818 · Received April 24, 2018

    Report

    Report Number
    9617032-2018-00573
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    May 5, 2017
    Report Date
    May 14, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA / 510(K)# IS CORRECTED TO BK050036.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 7010777. MEDICAL DEVICE EXPIRATION DATE: 05/31/2018 . DEVICE MANUFACTURE DATE: 01/10/2017. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 THAT BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES HAD ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299854 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7018943 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other