BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 7470928 · Received April 27, 2018

    Report

    Report Number
    1917413-2018-01072
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    June 29, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 103223 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® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN "CPT - 362753 - POOR SEPARATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313345 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7012769 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other