BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 7558502 · Received May 31, 2018

    Report

    Report Number
    1917413-2018-01502
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    November 16, 2015
    Report Date
    June 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): CORRECTED TO K911731. CORRECTED TO (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN HAD NO PBMC LAYER IN THE PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398185 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5061863 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other