BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BAG FOR MIS

    MDR report key: 7699290 · Received July 18, 2018

    Report

    Report Number
    3006425876-2018-00437
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 26, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K132658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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. RETURNED DEFECTIVE SAMPLE WAS EXAMINED AND THE REPORTED DEFECT CANNOT BE CONFIRMED. IT WAS FOUND THAT THE FOIL IS DRAWN IN THE BOTTOM PART OF THE BAG. NO HOLE/ RUPTURE WAS FOUND IN LOCATION OF DRAWN OF FOIL. THE FOIL IS STRETCHED/ DRAWN BUT DID NOT RUPTURED. THE DRAWN WAS CREATED FROM THE INSIDE OUT. IFU 940268-000000 SAYS THAT LARGE TISSUE SPECIMENS MAY NEED TO BE CUT INTO SMALLER PIECES FOR REMOVAL. FURTHERMORE, IT SAYS THAT THE MEMOBAG IS REMOVING THROUGH THE TROCAR INCISION SIDE. IF THE CONTENTS OF THE MEMOBAG ARE TOO LARGER TO PASS THROUGH THE TROCAR INCISION, THE INCISION MAY NEED TO BE ENLARGED TO FACILITATE REMOVAL OF THE MEMOBAG. IN THE EVENT, THAT ONE OF ABOVE ISSUES IS NOT FULFILLED, THE FOUND DEFECT CAN BE CAUSED. THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED AS IMPROPER METHOD OF USE DURING MEMOBAG REMOVAL DEPENDING ON CHARACTER OF FOUND DEFECT. IT WAS FOUND THAT THE FOIL IS STRETCHED/ DRAWN IN ONE PLACE. THE FOIL IS STRETCHED/ DRAWN BUT DID NOT RUPTURED. AS THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED IMPROPER METHOD OF USE ON THE CUSTOMER SIDE, NO CORRECTIVE I PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE EXTRACTION FROM THE UMBILICAL ACCESS THE BAG CONTAINING THE REMOVED GALLBLADDER, THE BAG BROKE AND REMAINED IN THE ABDOMEN. THE BAG WAS COMPLETELY REMOVED SOON AFTER. THE PROBLEM OCCURRED THREE MORE TIMES IN THREE DIFFERENT DAYS PRIOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXTRACTION FROM THE UMBILICAL ACCESS THE BAG CONTAINING THE REMOVED GALLBLADDER, THE BAG BROKE AND REMAINED IN THE ABDOMEN. THE BAG WAS COMPLETELY REMOVED SOON AFTER. THE PROBLEM OCCURRED THREE MORE TIMES IN THREE DIFFERENT DAYS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542372 EXTRACTION BAG FOR MIS CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 71F18C0775

    Patients

    Seq Age Sex Outcome Treatment
    1