BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® EDTA LAVENDAR TUBES

    MDR report key: 7475763 · Received May 1, 2018

    Report

    Report Number
    2618282-2018-00540
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    May 24, 2013
    Report Date
    June 1, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM "N/A" TO "K991702".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROTAINER® EDTA LAVENDAR TUBES HAD CLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318409 BD MICROTAINER® EDTA LAVENDAR TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 2159349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other