BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75

    MDR report key: 17781872 · Received September 20, 2023

    Report

    Report Number
    1125230-2023-00054
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Report Date
    September 20, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4). NO CUSTOMER SAMPLES OR PICTURES WERE RECEIVED. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. THIS CUSTOMER IS LOCATED IN (B)(6), WHICH HAS AN ALTITUDE OF APPROXIMATELY 5,509 FEET. THEREFORE, 454334 TUBES ARE NOT APPROPRIATE FOR USE AT THIS ELEVATION. HIGH ALTITUDE 3.2% SODIUM CITRATE TUBES WITH INCREASED VACUUM ARE AVAILABLE FOR SITES LOCATED 5,000 FEET OR MORE ABOVE SEA LEVEL. THE ALLEGED MALFUNCTION IS NOT JUSTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED TUBE ITEM 454334 UNDERFILLED. THE CUSTOMER IS LOCATED IN (B)(6), ELEVATION 5,000 FEET. THE CUSTOMER WAS RECOMMENDED TO USE HIGH ALTITUDE TUBE ITEM: 454331 FOR THEIR LOCATION AND WAS PROVIDED WITH THE APPROPRIATE PRODUCT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83531 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454334

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown