BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ

    MDR report key: 21708506 · Received March 27, 2025

    Report

    Report Number
    3020707080-2025-00001
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 13, 2023
    Report Date
    May 13, 2025
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    PMA / PMN Number
    K210625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 16TH 2023, A COMPLAINT WAS RECEIVED, BUT IT WAS NEVER EVALUATED FOR REPORTABILITY TO THE FDA. THIS WAS IDENTIFIED DURING A FDA-INSPECTION ON MARCH 25TH 2025, THEREFORE, WE ARE REPORTING IT NOW.

    Additional Manufacturer Narrative · 0

    UPDATE: REFERENCING MDR (B)(4) (SUBMITTED ON APRIL 3RD, 2025) IN BLOCK H10 IN SUPPLEMENTAL #1 MANUFACTURER MDR 3020707080-2025-00001. REF INITIAL MANUFACTURER MDR #3020707080-2025-00001. REF HCUS (B)(4). REF FFMW (B)(4).

    Description of Event or Problem · 0

    THE FROG VALVES (PART OF THE VAL1-G7-50) ARE LEAKING IN > 80% OF CASES AND HAVE PUNCHING DEFECTS. TODAY WE FOUND PARTS IN THE PATIENT AGAIN. FULL SUCTION CANNOT BE ACHIEVED WITH A DEFECT AND SOME OF THE VALVES ARE DRIPPING DIRTY AND LOSING A LOT OF GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472752 JAZZ FORCEPS VALVE ODC FUJIFILM MEDWORK GMBH VAL1-G7-50 22350660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other