BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDIPLAST WESTERGREN ESR SYSTEM

    MDR report key: 10683571 · Received October 15, 2020

    Report

    Report Number
    MW5097227
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 9, 2020
    Manufacturer
    POLYMEDCO, INC.
    Product Code
    JPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TOP OF ESR CAP (PIPETTE) BLEW OFF WHEN INSERTING INTO VIAL. WHEN INSERTING PIPETTE INTO VIAL, THE TOP OF THE PIPETTE (CAP) BLEW OFF AND BLOOD SHOT OUT OF THE TOP OF THE PIPETTE. WITH THE PRESSURE THAT IS NEEDED TO PUSH THE PIPETTE INTO THE VIAL, BLOOD WAS SHOT ALL THE WAY TO THE CEILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150280 SEDIPLAST WESTERGREN ESR SYSTEM TEST, ERYTHROCYTE SEDIMENTATION RATE JPH POLYMEDCO, INC. Y1319A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR