BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES

    MDR report key: 7434607 · Received April 16, 2018

    Report

    Report Number
    1917413-2018-00770
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    October 6, 2016
    Report Date
    April 13, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903646062
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5356756 , MEDICAL DEVICE EXPIRATION DATE: 2018-01-31, DEVICE MANUFACTURE DATE: 2015-12-22 ; MEDICAL DEVICE LOT #: 5251642, MEDICAL DEVICE EXPIRATION DATE: 2017-09-30, DEVICE MANUFACTURE DATE: 2015-09-08. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE 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 FOREIGN MATTER DESCRIBED AS ¿WHITE PARTICLES¿ WAS SEEN IN A BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277914 BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. SEE H.10 50382903646062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other