BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BAG FOR MIS

    MDR report key: 23392989 · Received October 27, 2025

    Report

    Report Number
    3006425876-2025-00998
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 30, 2025
    Report Date
    September 30, 2025
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KGY
    UDI-DI
    44026704760709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "CUSTOMER COMPLAINT REGARDING MEMOBAG PRODUCT WAS REPORTED. AS THE JOT NUMBER OF THE DEFECTIVE PRODUCT WAS NOT REPORTED, THE DHR REVIEW WAS NOT COMPLETED. THE REPORTED DEFECT CANNOT BE CONFIRMED BECAUSE THE DEFECTIVE DEVICES WERE NOT RETURNED FOR EXAMINATION. THE ROOT CAUSE FOR THESE COMPLAINTS CANNOT BE DETERMINED DUE TO UNAVAILABLE DEFECTIVE DEVICES. AS THE ROOT CAUSE WAS NOT DETERMINED, NO CORRECTIVE I PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE BAG BROKE THROUGH AT THE BOTTOM". ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT CAUSED A LONGER PROCEDURAL TIME. ANY PIECES THAT FELL INTO THE PATIENT WERE SUCCESSFULLY REMOVED. THE PATIENT'S STATUS IS REPORTED AS "UNKNOWN TO DATE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE BAG BROKE THROUGH AT THE BOTTOM". ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT CAUSED A LONGER PROCEDURAL TIME. ANY PIECES THAT FELL INTO THE PATIENT WERE SUCCESSFULLY REMOVED. THE PATIENT'S STATUS IS REPORTED AS "UNKNOWN TO DATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797982 EXTRACTION BAG FOR MIS BAG, INTENSTINE KGY TELEFLEX MEDICAL IPN004939 71F25C0982 44026704760709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown