BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EXTRACTION BAG FOR MIS

    MDR report key: 24334820 · Received February 13, 2026

    Report

    Report Number
    3006425876-2026-00165
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 16, 2026
    Report Date
    January 16, 2026
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KGY
    UDI-DI
    44026704760709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE DEFECTIVE SAMPLE WAS RECEIVED ON 16-FEB-2026. RECEIVED DEFECTIVE SAMPLE WAS PACKED IN PE BAG. THERE WAS RETURNED OPENED ORIGINAL POUCH AND THE WIRE. THE PHOTO SHOWS THE IDENTIFICATION LABEL ON THE POUCH COMPLYING WITH COMPLAINED DEVICE. THERE IS VISIBLE, THAT RETURNED WIRE. WIRE IS SLIGHTLY BEND IN 3 POINTS. WHITE PROTECTIVE TUBE COVERING THE WIRE IS UNDAMAGED. WIRE EYE AND THE LOOP GLUED TO THE BAG ARE IN GOOD CONDITION AND SHOW NO SIGNS OF USE. WIRE MUST BE GLUED TO THE FOIL WALL OF BAG BUT THE RETURNED WIRE HAD THE WHOLE AMOUNT OF GLUE ON THE WIRE. GLUE WAS PROBABLY FULLY DETACHED FROM FOIL. THE REPORTED DEFECT "DETACHED WIRE FROM BAG" CAN BE CONFIRMED BASED ON VISUAL INSPECTION ON RETURNED DEVICE. GLUE WHICH ENSURE THE FIRM CONNECTION BETWEEN WIRE AND THE BAG WAS FULLY DETACHED FROM THE BAG AND REMAINS ON THE WIRE. WIRE IS ASSEMBLED ACCORDING TO THE APPLICABLE WORK INSTRUCTION, THREADED THROUGH THE BAG ACCORDING TO THE APPLICABLE WORK INSTRUCTION, GLUED ON THE INNER SIDE OF THE BAG ACCORDING TO THE APPLICABLE WORK INSTRUCTION AND CLOSURE LOOP WAS CREATED ACCORDING TO THE APPLICABLE WORK INSTRUCTION. LOOP GLUED TO THE MEMOBAG ACCORDING TO THE APPLICABLE WORK INSTRUCTION IS PREPARED AND GLUED ACCORDING TO THE APPLICABLE WORK INSTRUCTION. LOOP IS GLUED TO THE PROTECTIVE TUBE PER THE APPLICABLE. THERE IS DEFINED 100% INSPECTION OF POSITION OF PROTECTIVE TUBES 003425-110014 (8 MM). THESE TUBES MUST NOT OVERLAP THE WIRE LOOPS AND MUST BE FIRMLY GLUED (MANUAL INSPECTION BY HANDS). WIRES WITH INSUFFICIENTLY GLUED PROTECTIVE TUBES SHOULD BE DETECTED AND IMMEDIATELY SCRAPPED. DETACHING OF WIRE LOOP SHOULD BE IMMEDIATELY DETECTED. WIRE DETACHED FROM THE BAG WALL IN PLACE OF CONTACT THESE 2 MATERIALS. FIRM CONNECTION IS REALIZED THROUGH THE GLUE 008051-000000 (ADHESIVE DILUTION 20%) WHICH IS APPLIED PER THE APPLICABLE WORK INSTRUCTIONS. BASED ON THE RETURNED WIRE, RESP. PERFORMED VISUAL INSPECTION IT WAS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF SEPARATION GLUE FROM THE BAG. NO DIFFERENCE FROM STANDARD PRODUCT WAS FOUND. RETURNED WIRE WAS NOT MECHANICALLY DAMAGED. ONLY 3 BEND POINTS ARE VISIBLE. PROBABILITY OF DAMAGING ON CUSTOMER SIDE IS LOW. PROBABILITY OF DAMAGING IN MANUFACTURING SITE IS LOW AS WELL. BASED ON INVESTIGATION OF R & D THERE CAN BE POTENTIAL ISSUE WITH INCORRECT THREADING WIRE THROUGH AN EYE. IN ABSENCE OF THREADING, THE WIRE CAN BE EASILY DETACHED FROM THE BAG. IT WAS SIMULATED ON ACTUALLY PRODUCED DEVICES. IT WAS POSSIBLE TO EASILY DETACH WIRE FROM BAG BUT NOT IN THE GLUE AREA. GLUE VERY FIRMLY HOLD ON THE BAG. THERE WAS DAMAGED THE GLUED EYE. IT IS THE FIRST OCCURRENCE OF THIS TYPE OF DEFECT ON MEMOBAG LINE. NO NC OR CUSTOMER COMPLAINT WERE RECEIVED SINCE THE TRANSFER OF MEMOBAG PRODUCTION TO ZDAR SITE. CUSTOMER COMPLAINT REGARDING MEMOBAG PRODUCT WAS REPORTED. AS THE LOT NUMBER OF THE DEFECTIVE PRODUCT WAS REPORTED, THE DHR REVIEW WAS COMPLETED. THE REVIEW OF DHR REVEALED NO PRODUCTION ISSUES AT THE TIME OF MANUFACTURING OF THE COMPLAINED LOT. REPORTED DEFECT CAN BE CONFIRMED. CLOSURE WIRE WAS DETACHED FROM THE BAG. THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED AS "UNDETERMINED / UNKNOWN". INVESTIGATION DID NOT RESULT TO THE IDENTIFICATION OF ROOT CAUSE. AS THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED AS "UNDETERMINED / UNKNOWN", NO CORRECTIVE / PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CLOSURE WIRE CAME OUT FROM THE MEMOBAG WHEN THE USER ATTEMPTED TO CLOSE IT DURING USE. THEREFORE, THE BAG WAS REMOVED AND REPLACED WITH A NEW UNIT, BY WHICH THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. NOTHING FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CLOSURE WIRE CAME OUT FROM THE MEMOBAG WHEN THE USER ATTEMPTED TO CLOSE IT DURING USE. THEREFORE, THE BAG WAS REMOVED AND REPLACED WITH A NEW UNIT, BY WHICH THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. NOTHING FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397796 WECK EXTRACTION BAG FOR MIS BAG, INTESTINE KGY TELEFLEX MEDICAL 71F24J1506 44026704760709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.| NONE REPORTED.