BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7467186 · Received April 26, 2018

    Report

    Report Number
    9617032-2018-00768
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 1, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6235740. MEDICAL DEVICE EXPIRATION DATE: 01/31/2018. DEVICE MANUFACTURE DATE: 08/22/2016. MEDICAL DEVICE LOT #: 6251813. MEDICAL DEVICE EXPIRATION DATE: 03/31/2018. DEVICE MANUFACTURE DATE: 09/07/2016. 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 LABEL ISSUES 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 THE BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES CONTAINED DEFECTIVE BARCODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310073 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6235740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other