BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTAINER SST GOLD

    MDR report key: 7492574 · Received May 7, 2018

    Report

    Report Number
    2243072-2018-00589
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    February 7, 2013
    Report Date
    June 1, 2018
    Manufacturer
    BECTON DICKINSON CARIBE LTD
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 MICROTAINER SST GOLD TUBES HAD POOR QUALITY SERUM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335312 MICROTAINER SST GOLD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON CARIBE LTD 2094492

    Patients

    Seq Age Sex Outcome Treatment
    1 Other