BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 7440757 · Received April 18, 2018

    Report

    Report Number
    1917413-2018-00866
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    November 16, 2016
    Report Date
    June 9, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JKA. PMA / 510(K)# IS CORRECTED TO K981013.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS THE CUSTOMER FACILITY FOR INVESTIGATION. RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "DEEP PURPLE SPOT" WAS FOUND EMBEDDED IN A BD VACUTAINER® EDTA 2K. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283440 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6124784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other