BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 9359284 · Received November 21, 2019

    Report

    Report Number
    1000317571-2019-00115
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 31, 2019
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL PM'S WERE COMPLETED. AFFECTED AMOUNT: 1PC. DUODERM GEL 30G WAS MANUFACTURED UNDER SAP CODE 1002859 AND MANUFACTURING LOT NUMBER 7L05547. LOT # 7L05547 WAS STERILIZED UNDER LOT 17L05K5086 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY BAXTERS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN-PROCESS TESTING AND PACKAGING OF PRODUCT WERE ALL RUN IN ACCORDANCE WITH PI12-017 VER. 25.0 FOR GEL FILLING AND FINAL PACKAGING. VISUAL INSPECTION IN ACCORDANCE WITH PR20-011 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS RAISED DURING THE MANUFACTURING PROCESS OF LOT 7L05547. QUERY RUN (B)(6) 2019: THERE ARE 3 COMPLAINTS FOR THIS LOT WITHIN TW8.7. TWO OF THESE COMPLAINTS ARE FOR THE SAME COMPLAINT ISSUE AND SAME MALFUNCTION CODE. A PHOTOGRAPH HAS BEEN RECEIVED AND HAS BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPH CONFIRMS THE EXPECTED PRODUCT AND COMPLAINT ISSUE. ON REVIEW OF THE PHOTOGRAPH THERE IS NOWHERE ON THE MACHINE TO PIERCE A HOLE IN THE TUBE IN THIS POSITION. THE TUBES ARE HANDLED BY OPERATORS TO BE PACKED FOR STERILIZATION AND THEN PACKED INTO THE CARTONS ONCE RETURNED FROM STERILIZATION. THE OPERATORS WOULD FEEL A GEL LEAK AS IT WOULD HAVE COVERED THE TUBE. OPERATORS HAVE BEEN INFORMED OF THE COMPLAINT ISSUE.

    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. DEVICE 1 OF 1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT BOX WAS INTACT, HOWEVER, A TUBE WAS NOTED TO BE "BADLY DENTED AND WAS DAMAGED TO THE EXTENT IT COULD NO LONGER BE USED". PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE SUBMITTED BY THE COMPLAINANT. IT WAS REPORTED THE PRODUCT WAS NOT USED ON A PATIENT. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151425 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING NOT APPLICABLE NAE CONVATEC LTD 187987 7L05547

    Patients

    Seq Age Sex Outcome Treatment
    1