BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM SYNERGY

    MDR report key: 7792579 · Received August 17, 2018

    Report

    Report Number
    9618003-2018-01145
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED, AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. BATCH RECORD REVIEW: LOT 7H05710 WAS MANUFACTURED ON 08/31/2017, 23A LINE, WITH A TOTAL OF (B)(4) UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 10/05/2020, DESCRIPTION ESTEEM PCH URO STD CLR FUT 30MM (1X30)FR TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT. SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1172569 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: THERE IS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE RESULTS OF THE PRELIMINARY INVESTIGATION, NO HARM WAS REPORTED FROM ANY OF THE COMPLAINANT, ALL DOCUMENTATION REVISED WERE IN ACCORDANCE WITH THE APPLICABLE PROCEDURES. THE TWO COMPLAINTS INCLUDED IN THIS PRELIMINARY INVESTIGATION HAVE PICTURES CONFIRMING THE ISSUE REPORTED. THE SIGNIFICANT RATING OF THIS EVENT IS CONSIDERED MAJOR. DURING THE PRELIMINARY INVESTIGATION CONDUCTED WITH THE MANUFACTURING SUPERVISORS, PROCESS ENGINEER, QUALITY SUPERVISOR FOR THE COMPLAINTS REPORTED DUE TO MALFUNCTION, THE FOLLOWING CONDITIONS WERE EVALUATED, MATERIAL, PERSONNEL, METHOD, ENVIRONMENT AND MACHINE. AFTER THIS ASSESSMENT, THE TRIAGE TEAM IDENTIFIED THE FAILURE OCCURRED DUE TO PERSONNEL, THE COLLAR AND WAFER COMPONENTS ARE MANUALLY PLACED IN THE POUCH BY THE MANUFACTURING PERSONNEL AND DURING THIS PROCESS, PERSONNEL INADVERTENTLY DID NOT PLACE THE COLLAR AND WAFER IN THE CORRECT POSITION. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "THE FLANGE IS NOT PLACED AND NOT STUCK IN THE MIDDLE OF THE CIRCLE WHERE IT SHOULD BE." THIS OCCURRED ON 30 DEVICES. THE PRODUCT CANNOT BE USED BY PATIENT. NO HARM WAS REPORTED. PHOTOS DEPICTING THE COMPLAINT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634211 ESTEEM SYNERGY POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 410312 7H05710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown