BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 17076751 · Received June 7, 2023

    Report

    Report Number
    9618003-2023-00576
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Report Date
    May 18, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). DEALER: SHIBATA INTECH. 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. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Additional Manufacturer Narrative · 0

    RETURNED SAMPLE EVALUATION: NO PHOTO ASSOCIATED WITH THIS CASE WAS RECEIVED FOR EVALUATION. BATCH RECORD REVIEW: THE LOT 2C04854 WAS MANUFACTURED ON 30 MAR 2022 DOYEN B MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 28 AUG 2023, 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 1000915 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. INVESTIGATION CONCLUSION: SYMPTOM: TRAPPED IN THE SEAL 1W: A DRESSING WAS LOCATED IN THE SEALING AREA 2W: DURING THE TRANSPORTATION ON THE CONVEYOR THE DRESSING GET 3W: ONE OF THE PINS THAT GUIDES THEIR PATH WAS NOT RETRACTING ON TIME 4W: PIN STOPPER THAT ALLOW GUIDES TO TURN DOWN SIMULTANEOUSLY WERE DAMAGED 5W: PIN STOPPER AND GUIDES MECHANICALS WEARS. (MACHINE). AN EVALUATION WAS DONE IN THE TRANSPORTATION SYSTEM, SEALING STATION AND PRIMARY PACKAGING PROCESS IN DOYEN B AND IT WAS OBSERVED WHEN ONE OF THE PINS THAT GUIDE THE DRESSING THROUGH THE CONVEYOR GET RETIRED FIRST, THE SECOND ONE PUSHES AND DISTORTS THE CENTRALIZED POSITION OF THE PIECES TAKING THEM TO THE SEALING AREA. ALL THE OTHER PROCESS VARIABLES WERE VERIFIED AS PART OF THE INVESTIGATION AND ALSO IT WAS FOUND AN OPPORTUNITY IN THE CURRENT MACHINE DETECTION SYSTEM: MATERIAL: NO ISSUES WERE FOUND. MANPOWER: OPPORTUNITIES WERE FOUND RELATED TO EXECUTION OF THE INSPECTION PROCESS AS PER PROCESS INSTRUCTION (PI). METHOD: THERE IS AN OPPORTUNITY RELATED TO HAVE A DETECTION SYSTEM TO ENSURE TO CATCH DRESSING TRAPPED IN THE SEAL DURING MANUFACTURING PRODUCTION. MEASUREMENT: NO GAPS RELATED WITH THIS VARIABLE WERE IDENTIFIED. ENVIRONMENT: NO GAPS RELATED WITH THIS VARIABLE WERE IDENTIFIED. MACHINE: MECHANICAL WEARS OVER TIME. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT RECORD HAS BEEN APPROVED AND WAS 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. FDA REGISTRATION NUMBER REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIMARY PACKAGE WAS SEALED WITH PRODUCT. THE DEVICE WAS NOT USED BY END USER. NO PHOTO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330785 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 2C04854

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown