BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV-II (NON-STERILE)

    MDR report key: 163392 · Received April 14, 1998

    Report

    Report Number
    1627487-1998-00018
    Event Type
    Malfunction
    Date Received
    April 14, 1998
    Date of Event
    March 1, 1998
    Report Date
    April 14, 1998
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MNJ
    Removal / Correction Number
    Z-162/3-8
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON OCCASION, THE VALVE WILL NOT GIVE ENOUGH RETURN. IT IS NOT OPENING TO ATMOSPHERE WHEN IT SHOULD. THE VALVE APPEARED TO BE OCCLUDED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRV-II (NON-STERILE) VACUUM RELIEF VALVE MNJ QUEST MEDICAL, INC. 4003203 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *