BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-DRAIN CENTESIS CATHETER

    MDR report key: 11938063 · Received June 4, 2021

    Report

    Report Number
    11938063
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 24, 2021
    Manufacturer
    MERMAID MEDICAL A/S
    Product Code
    GCB
    UDI-DI
    15711055001981
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF DIABETES MELLITUS, HYPERTENSION, PROGRESSIVE DYSPNEA, AND PLEURAL EFFUSION WAS ADMITTED FOR AN ULTRASOUND-GUIDED THORACENTESIS. WHEN OPENING THE M-DRAIN 5F X 7 CM CENTESIS CATHETER, HEALTH CARE PROVIDER(S) NOTICED THERE WAS A 10 CM NEEDLE IN THE 7 CM SHEATH. ANOTHER DEVICE WAS OPENED WITH THE SAME ISSUE WHERE THE NEEDLE WAS TOO LONG. BOTH M-DRAIN CENTESIS CATHETER HAD THE SAME LOT NUMBER. THIS EQUIPMENT WAS NOT USED ON THE PATIENT AS THE TECHNOLOGIST AND PA NOTICED THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834510 M-DRAIN CENTESIS CATHETER NEEDLE, CATHETER GCB MERMAID MEDICAL A/S D40105007 P001510 15711055001981

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA