BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTAINER SST GOLD

    MDR report key: 7578620 · Received June 7, 2018

    Report

    Report Number
    2618282-2018-00425
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    December 3, 2015
    Report Date
    June 9, 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 · 0

    PMA / 510(K)# IS CORRECTED TO K991702.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(4). DEVICE MANUFACTURE DATE: 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 MICROTAINER SST GOLD TUBES WERE UNDER FILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423121 MICROTAINER SST GOLD BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other