BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® EDTA LAVENDAR TUBES

    MDR report key: 7485287 · Received May 3, 2018

    Report

    Report Number
    2618282-2018-00561
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    June 13, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA / 510(K) # HAS BEEN CORRECTED TO K991702.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE AWARENESS DATE HAS BEEN USED FOR THIS FIELD. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROTAINER® EDTA LAVENDER TUBES HAD ISSUES WITH CLOTTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325587 BD MICROTAINER® EDTA LAVENDAR TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 2244484

    Patients

    Seq Age Sex Outcome Treatment
    1 Other