BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BAG FOR MIS

    MDR report key: 12915694 · Received December 2, 2021

    Report

    Report Number
    3006425876-2021-01140
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 24, 2021
    Report Date
    November 26, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER COMPLAINT REGARDING MEMOBAG PRODUCT WAS REPORTED. AS THE LOT NUMBER OF THE DEFECTIVE PRODUCT WAS REPORTED, THE OHR REVIEW WAS COMPLETED. THE REVIEW OF OHR REVEALED NO PRODUCTION ISSUES AT THE TIME OF MANUFACTURE OF THE COMPLAINED LOT. REPORTED DEFECT CAN BE CONFIRMED. CLOSURE WIRE IS RUPTURED , AND PART OF WHITE PROTECTIVE TUBE IS MISSING. THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED AS INTENTIONAL USER ERROR (MISUSE) RELATED. CLOSURE WIRE WAS RUPTURED BY IMPROPER METHOD OF USE SAME AS WHITE PROTECTIVE TUBE WHICH WAS RUPTURED TO MINIMALLY 4 PARTS AS THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED AS INTENTIONAL USER ERROR (MISUSE) RELATED, NO CORRECTIVE/PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). CUSTOMER COMPLAINT REGARDING MEMOBAG PRODUCT WAS REPORTED. AS THE JOT NUMBER OF THE DEFECTIVE PRODUCT WAS REPORTED, THE DHR REVIEW WAS COMPLETED. THE REVIEW OF DHR REVEALED NO PRODUCTION ISSUES AT THE TIME OF MANUFACTURE OF THE COMPLAINED LOT. THE REPORTED DEFECT CANNOT BE CONFIRMED BECAUSE THE DEFECTIVE DEVICE WAS NOT RETURNED FOR EXAMINATION. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CLEARLY DETERMINED BECAUSE OF UNAVAILABLE DEFECTIVE DEVICE AND JACK OF INFORMATION ABOUT REPORTED DEFECT. AS THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED, NO CORRECTIVE/ PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    THE SMALL PLASTIC SHEATH OF THE WIRE UNRAVELLED AND DETACHED FROM THE WIRE. IT MIGRATED TO THE OPERATING AREA. THE PART OF THE SHEATH WAS RECOVERED.

    Description of Event or Problem · 0

    THE SMALL PLASTIC SHEATH OF THE WIRE UNRAVELLED AND DETACHED FROM THE WIRE. IT MIGRATED TO THE OPERATING AREA. THE PART OF THE SHEATH WAS RECOVERED.

    Description of Event or Problem · 0

    THE SMALL PLASTIC SHEATH OF THE WIRE UNRAVELLED AND DETACHED FROM THE WIRE. IT MIGRATED TO THE OPERATING AREA. THE PART OF THE SHEATH WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812600 EXTRACTION BAG FOR MIS KGY TELEFLEX MEDICAL 71F21H1439

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown