BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 7475848 · Received May 1, 2018

    Report

    Report Number
    1917413-2018-01281
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    July 20, 2017
    Report Date
    April 27, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    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 112628 WITH THE INCIDENT LOT WAS OBSERVED. 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® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD AIR BUBBLES IN THE ADDITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317775 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6342501 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other