BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 15742218 · Received November 7, 2022

    Report

    Report Number
    1000317571-2022-00342
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Report Date
    October 13, 2022
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    UDI-DI
    00768455172979
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 2. (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. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY H6: IMDRF INVESTIGATION FINDINGS HAS BEEN SELECTED AS C22 FOR TERM "IMPROPER PRINTING WHILE LABELLING PROCESS" A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. DUODERM H/ACTIVE GEL (3TBEX30G) STER US WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1002859 AND MANUFACTURING LOT NUMBER 1L00201 ON 28 NOVEMBER 2021. LOT # 1L00201 WAS STERILISED UNDER REFERENCE 21K15K6161 AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY BAXTER. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1L00201. THERE ARE 3 COMPLAINTS AGAINST LOT 1L00201, INCLUDING THIS COMPLAINT. THERE ARE AN ADDITIONAL 2 COMPLAINTS FOR STAINS ON PRIMARY PACKAGING AND BUMPS ON PRIMARY PACKAGING. 1 PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WIS). THE PHOTOGRAPHS CONFIRM THE EXPECTED LOT NUMBER, PRODUCT AND THE COMPLAINT ISSUE. THE IMAGE SHOWS 3 TUBES WITH RED RINGS MARKING THE STAINING, WHERE BLACK PRINTED LABELLING IS SHOWN TO BE OFFSET AND WHAT APPEARS TO BE A SLIGHT CHIP IN THE PAINT OF THE PRIMARY TUBE. THE OTHER RED RINGS APPEAR TO BE MARKING TUBE DAMAGE. IT WAS NOT POSSIBLE TO HAVE THE SAMPLE RETURNED DUE TO COURIER RESTRICTIONS IN THE LATAM (LATIN AMERICA) REGION FOR THE PRODUCT. A PREVIOUS NONCONFORMANCE WAS OPENED FOR THIS COMPLAINT BATCH. TRIAGE IDENTIFIED THAT THE PHOTOGRAPHS RECEIVED SHOWED THE TUBE TO HAVE PRINTED INFORMATION NOT APPLIED AT THE MANUFACTURING SITE. LATAM (LATIN AMERICA) REGULATORY REPRESENTATIVES CONFIRMED THIS RELABELLING ACTIVITY IS COMPLETED IN CARIBETRANS LATAM (LATIN AMERICA) WAREHOUSES DUE TO LOCAL REQUIREMENTS USING AN INKJET PRINTER. THE OFFSET IN THE PRINTING IN THIS COMPLAINT WILL BE A PRINT DEFECT FROM THE CARIBETRANS RELABELLING PROCESS FOR THE LATAM (LATIN AMERICA) REGION. THE SUPPLIER HAS BEEN MADE AWARE, THE DEFECT CIRCLED RED ON THE PHOTOGRAPH APPEARED TO BE A SLIGHT PAINT CHIP, ALLOWABLE BY THE STANDARDS OF ACCEPTABILITY FOR THIS PRODUCT. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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: 1000317571

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS STAIN FOUND ON ALUMINUM GEL TUBE. THE PRODUCT WAS NOT USED ON PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

    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
    208394 DUODERM PASTE AND GELS NOT APPLICABLE NAE CONVATEC LTD 187987 1L00201 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown