BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED BLOOD COLLECTION TUBE

    MDR report key: 11921649 · Received June 2, 2021

    Report

    Report Number
    1125230-2021-00050
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. NO CUSTOMER PICTURES WERE RECEIVED. NO MATERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES THE VACUUM IN THE TUBE DOES NOT FILL TO THE APPROPRIATE LEVEL FOR TESTING. THIS IS BOTH WHEN YOU ARE DRAWING WITH A VACUTAINER (STRAIGHT NEEDLE) AND WHEN YOU DRAW WITH A SYRINGE AND TRANSFER INTO TUBE. CUSTOMER ADVISES AT LEAST WHEN YOU HAVE A SYRINGE YOU CAN PUSH A LITTLE MORE INTO THE TUBE BUT SOMETIME THAT CAN HEMOLYZE THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822604 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1