BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUEST 67714

    MDR report key: 16701636 · Received April 6, 2023

    Report

    Report Number
    MW5116453
    Event Type
    Other
    Date Received
    April 6, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 4, 2023
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MPS 3 DISPOSABLE LEAKING. PIN SIZE HOLE IN THE STERILE TUBING. REPORTED TO MANUFACTURER. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440702 QUEST 67714 HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR QUEST MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male