BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTGUN CARTRIDGE KT

    MDR report key: 21462077 · Received February 25, 2025

    Report

    Report Number
    3012495575-2025-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 20, 2025
    Manufacturer
    SURGENTEC, LLC
    Product Code
    FMF
    UDI-DI
    00858406007433
    PMA / PMN Number
    K180937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA.

    Description of Event or Problem · 0

    REP SENT IN A USAGE SHEET WITH A CASE DATE ON (B)(6) 2025, WHICH INCLUDED THE GG-K-1000 WHICH HAD AN EXPIRATION DATE OF JANUARY 27TH, 2025. THE REP ALSO STATED THAT THIS WAS THE SIXTH CASE OF THE DAY SO WHEN SHE READ OUT THE EXPIRATION DATES, NO ONE NOTICED THAT THE EXPIRY DATE HAD PASSED. AT THE TIME OF SURGERY, IT DID NOT CAUSE ANY PATIENT HARM DURING THE CASE. THE PATIENT DID NOT STAY UNDER ANESTHESIA LONGER THAN INITIALLY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075087 GRAFTGUN CARTRIDGE KT PISTON SYRINGE FMF SURGENTEC, LLC GG-K-1000 C2458821A 00858406007433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown