BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7483938 · Received May 3, 2018

    Report

    Report Number
    9617032-2018-00846
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    July 9, 2017
    Report Date
    April 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 120981 WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES HAD "INCORRECT CAP COLOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325723 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7082548 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other