BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® Z 5 ML 13X75MM

    MDR report key: 7567068 · Received June 4, 2018

    Report

    Report Number
    9617032-2018-02130
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    October 19, 2017
    Report Date
    May 9, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER ON: UNKNOWN. THE INVESTIGATION DATE HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6112841, MEDICAL DEVICE EXPIRATION DATE: 04/30/2018, DEVICE MANUFACTURE DATE: 04/21/2016. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® Z 5 ML 13X75MM CONTAINED GLASS FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409935 BD VACUTAINER® Z 5 ML 13X75MM BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6334521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other