BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7582741 · Received June 8, 2018

    Report

    Report Number
    9617032-2018-01122
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    August 18, 2016
    Report Date
    May 31, 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6120817, MEDICAL DEVICE EXPIRATION DATE: 08/31/2017, DEVICE MANUFACTURE DATE: 04/29/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES HAD MOLDING DEFECTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426296 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6141852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other