BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV

    MDR report key: 454928 · Received April 16, 2003

    Report

    Report Number
    1649914-2003-00023
    Event Type
    Malfunction
    Date Received
    April 16, 2003
    Date of Event
    March 8, 2003
    Report Date
    April 16, 2003
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT AN AMSECT MEETING, THE CUSTOMER REPORTED LEAKING WITH THE VALVE. THE AMOUNT AND LOCATION IS UNKNOWN. THE CUSTOMER RECEIVES THE VALVE IN A PACK. THE CUSTOMER STATED IT IS FROM AN OLDER LOT-THEY DO NOT ROTATE THEIR PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RLV VACCUM RELIEF VALVE MNJ QUEST MEDICAL, INC. 4103202 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN