BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 7567311 · Received June 4, 2018

    Report

    Report Number
    1917413-2018-01534
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    March 15, 2017
    Report Date
    June 15, 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 UPDATED TO JKA. 510(K)# UPDATED TO K981013.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE UPDATED TO JKA. 510(K)# UPDATED TO K981013.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) GIVEN FOR THIS DEVICE. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. NO DHR WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® EDTA 2K HAD FM IN THE TUBE. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408904 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5300684

    Patients

    Seq Age Sex Outcome Treatment
    1 Other