BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 7469073 · Received April 27, 2018

    Report

    Report Number
    1917413-2018-01068
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    January 7, 2017
    Report Date
    June 8, 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

    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 COCKED STOPPER WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® EDTA 2K HAD DEFORMED RUBBER STOPPERS AND THE CAPS WERE INSTALLED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313128 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6161930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other