BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® K2E TUBES

    MDR report key: 7463181 · Received April 25, 2018

    Report

    Report Number
    2618282-2018-00335
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 4, 2017
    Report Date
    April 20, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    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 #: 6081956, EXPIRATION DATE: 2017-08-31, MANUFACTURE DATE: 2016-03-21. MEDICAL DEVICE LOT #: 5281707, EXPIRATION DATE: 2017-03-31, MANUFACTURE DATE: 2015-10-08. MEDICAL DEVICE LOT #: 6328901, EXPIRATION DATE: 2018-04-30, MANUFACTURE DATE: 2016-11-23. MEDICAL DEVICE LOT #: 6305840, EXPIRATION DATE: 2018-04-30, MANUFACTURE DATE: 2016-10-31. INITIAL REPORTER PHONE#: (B)(6). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 90009 WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 90009 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 MICROTAINER® K2E TUBES HAD CLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300668 BD MICROTAINER® K2E TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 6123990

    Patients

    Seq Age Sex Outcome Treatment
    1 Other