BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 8200216 · Received December 27, 2018

    Report

    Report Number
    1649914-2018-00100
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Report Date
    December 27, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    MJJ
    PMA / PMN Number
    K922356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED INCIDENT OCCURRED OUTSIDE OF THE US. THIS MEDWATCH IS BEING SUBMITTED BECAUSE QUEST DISTRIBUTES A SIMILAR DEVICE IN THE US. AN INVESTIGATION WILL BE CONDUCTED ON THE COMPLAINT SAMPLES AND A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WITH THE VALVE. THE REPORT STATES THAT PARTICULATE MATTER WAS FOUND IN THE HOUSING OF THE VALVE DURING CIRCUIT ASSEMBLY. THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040540 RETROGUARD ARTERIAL SAFETY VALVE CPB CHECK VALVE MJJ QUEST MEDICAL, INC 4007100 0560968E06

    Patients

    Seq Age Sex Outcome Treatment
    1