BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR TACSHIELD

    MDR report key: 6095395 · Received November 11, 2016

    Report

    Report Number
    3011175548-2016-00009
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    UDI-DI
    00650862316339
    PMA / PMN Number
    K100076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS: ENGINEERING REVIEWED THE STERILIZATION AND DEVICE HISTORY RECORDS FOR THE PRODUCT IN QUESTION AND REVIEW SHOWED THAT CRITERIA WAS MET. ENGINEERING SUMMARY: THE PICTURE PROVIDED BY THE HOSPITAL SHOWS A "SPARE" PIECE OF TACSHIELD AFTER IMPLANTING ONE OF THE DEVICES. THE SPARE PART WAS DISCARDED RATHER THAN SENT BACK FOR EVALUATION, SO ENGINEERING CANNOT CONFIRM THE TACSHIELD IN THE PICTURE WAS THE ONE SCRAPPED IN PROCESS. A REVIEW OF PAST PRODUCT COMPLAINTS BY THE COMPLAINTS DEPARTMENT SHOW THAT WE HAVE NOT HAD A COMPLAINT FOR MULTIPLE PARTS IN THE SAME PACKAGING. GIVEN THE CONTROLS IN PLACE, THIS IS LIKELY AN ISOLATED INCIDENT THAT WAS NOT IDENTIFIED DURING THE 100% INSPECTION VISUAL INSPECTION JUST PRIOR TO PLACING PRODUCT IN A HANDLING SLEEVE IN PROCESS. AS FAR AS THE ASSESSMENT OF WHETHER OR NOT THE PARTS WERE STERILE, ENGINEERING IS CONFIDENT THAT THE TWO PIECES OF C-QUR TACSHIELD CITED IN THE COMPLAINT WERE NOT A WORST CASE CHALLENGE WHEN COMPARED TO THE VALIDATIONS THAT HAD BEEN PERFORMED. BASED ON THE ASSESSMENT DETAILED IN THE INVESTIGATION AND THE RESULTS FROM THOSE STERILIZATION VALIDATIONS, THE PARTS ARE STERILE AND SHOULD PERFORM AS INTENDED. CLINICAL EVALUATION: IF THERE IS A COMPROMISE IN THE INTEGRITY OF THE PACKAGING OF A STERILE DEVICE, IT WOULD BE NOTICED PRIOR TO BEING INTRODUCED TO THE SURGICAL SITE. THIS MAY CREATE A DELAY IN THE PROCEDURE WHILE A SECOND DEVICE IS LOCATED AND PREPPED. THE COMPLAINT STATES THAT TWO PIECES OF MESH WERE FOUND INSIDE THE STERILE PACKET INSTEAD OF JUST ONE. IN THE EVENT THAT AN ADDITIONAL PIECE OF THE PRODUCT WAS ADDED TO THE PACKAGE AFTER RECEIPT AT THE FACILITY THE SEALED POUCH AND THE SEAL ON THE OUTER BOX WOULD BE BROKEN. THE INSTRUCTIONS FOR USE WARN, 'THIS DEVICE IS SUPPLIED STERILE. PLEASE INSPECT PACKAGING TO ENSURE IT IS INTACT AND NOT DAMAGED PRIOR TO USE.'

    Description of Event or Problem · 1

    DURING AN OPEN VENTRAL HERNIA CASE THERE WERE TWO PIECES OF MESH IN THE STERILE PACKET OF A TACSHIELD RATHER THAN ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748136 C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP 31633 408265 00650862316339

    Patients

    Seq Age Sex Outcome Treatment
    1