BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7450273 · Received April 23, 2018

    Report

    Report Number
    1917413-2018-00961
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 2, 2016
    Report Date
    May 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE MANUFACTURER WAS CHANGED TO BROKEN BOW.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6096755, MEDICAL DEVICE EXPIRATION DATE: 08/31/2017, DEVICE MANUFACTURE DATE: 04/05/2016, MEDICAL DEVICE LOT #: 6161932, MEDICAL DEVICE EXPIRATION DATE: 10/31/2017, DEVICE MANUFACTURE DATE: 06/09/2016. (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. 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® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES ARE CLOTTING WHEN THEY SHOULDN'T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292733 BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other