BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 742071 · Received July 21, 2006

    Report

    Report Number
    1649914-2006-00060
    Event Type
    Malfunction
    Date Received
    July 21, 2006
    Report Date
    July 21, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 25595.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING INCOMING INSPECTION, DURING FURTHER MANUFACTURING AND ON THE FIELD, THEY HAVE FOUND CRACKS ON THE HOUSING OF THE DEVICE. SAMPLES WERE SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200, LOT NUMBERS 25304 & 25595.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFETY VALVE FLOW CHECK VALVE MJJ QUEST MEDICAL, INC. 4007200 25304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN