BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BAG FOR MIS

    MDR report key: 7625369 · Received June 21, 2018

    Report

    Report Number
    3006425876-2018-00384
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 28, 2018
    Report Date
    May 29, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS THE LOT NUMBER OF THE DEFECTIVE PRODUCT WAS REPORTED, THE DHR REVIEW OF THE COMPLAINED LOT COULD BE COMPLETED. FROM THE REVIEWED DATA IT IS OBVIOUS THAT THE COMPLAINED JOT WAS PRODUCED IN DECEMBER 2016. THERE WERE SCRAPPED 20 PIECES DURING PRODUCTION OF COMPLAINED JOT IN TOTAL. 8 PIECES WERE SCRAPPED DURING OPERATION "SEAL AND FUNCTION INSPECTION (QC}", 2 PIECES WERE SCRAPPED DURING OPERATION "PRINTING LABELS ON BOXES" AND 10 PIECES WERE USED AS BIO SAMPLES. IT WAS FOUND OUT THAT 1 SHIPPING BOX WITH 220 PCS OF THIS LOT WAS DAMAGED IN STERILIZATION COMPANY BBF. THIS BOX WAS RETURNED BACK TO ZDAR FACILITY, NC 60037720 WAS OPENED AND THIS BOX WAS REPACKED UNDER THIS NC. 195 PCS WERE SCRAPPED BECAUSE OF DAMAGED POUCHES WITH PRODUCTS AND 25 PCS WERE RELEASED TO THE MARKET. THIS ISSUE HAS NO IMPACT TO THE REPORTED DEFECT. INCOMING INSPECTION AND FINAL INSPECTION RECORDS OF RAW MATERIAL/SEMI-FINISHED MATERIAL WERE REVIEWED. LOTS WERE CHECKED BY QC INSPECTION AND WERE RELEASED WITHOUT ANY DEFECT OBSERVED. FINAL INSPECTION RECORD OF COMPLAINED LOT WAS REVIEWED. LOT WAS CHECKED BY FINAL QC INSPECTION AND WAS RELEASED WITHOUT ANY DEFECT OBSERVED. 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 OHR 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 BACK TO EXAMINATION. 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. IFU SAYS THAT THE CARE SHOULD BE TAKEN AT ALL TIMES TO AVOID CONTACT OF THE BAG WITH SHARP INSTRUMENTS, CUTTING DEVICES, MORCELLATORS, ELECTROCAUTERY OR LASER DELIVERY DEVICES. IN THE EVENT, THAT ONE OF ABOVE ISSUES IS NOT FULFILLED, THE COMPLAINED DEFECT (BROKEN BAG) CAN BE CAUSED. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CLEARLY DETERMINED BECAUSE OF POOR INFORMATION ABOUT THE REPORTED DEFECT AND UNAVAILABLE DEFECTIVE DEVICE. AS THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED, NO CORRECTIVE I PREVENTIVE ACTIONS IN PRODUCTION ARE DEEMED NECESSARY TO INTRODUCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEMOBAG BURST AT THE BOTTOM WITH THE SPECIMEN IN IT, WHEN THE DOCTOR WANTED TO REMOVE IT.

    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 THE MEMOBAG BURST AT THE BOTTOM WITH THE SPECIMEN IN IT, WHEN THE DOCTOR WANTED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468225 EXTRACTION BAG FOR MIS GCJ TELEFLEX MEDICAL 71F16L1861

    Patients

    Seq Age Sex Outcome Treatment
    1