BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 19141140 · Received April 19, 2024

    Report

    Report Number
    1000317571-2024-00025
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 25, 2024
    Report Date
    March 25, 2024
    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

    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. 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 3H00021 ON 31 AUGUST 2023. LOT # 3H00021 WAS STERILISED UNDER ANDERSEN CALEDONIA BATCH SSP170823-1 AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY ANDERSEN CALEDONIA. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 3H00021. THIS IS THE FIRST COMPLAINT OUT OF 2 FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. THIS COMPLAINT IS FOR A HOLE AND LEAKAGE IN THE TUBE, AND THE OTHER COMPLAINT IS FOR DENTED TUBE. BOTH COMPLAINTS ARE RELATED AND IDENTIFY TWO MALFUNCTIONS FOR THE SAME PRIMARY TUBE. 1 PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPH CONFIRMS THE PRODUCT AND THE COMPLAINT ISSUE WHERE THE BACK OF THE TUBE EXHIBITS DAMAGE AT THE BASE OF THE TUBE. THERE IS EVIDENCE OF DRIED GEL ON THE TUBE CRIMP AND ABOVE WHERE A DARK PERFORATION IS SEEN IN THE TUBE. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE. AS PER WORK INSTRUCTIONS (WI), ACCEPTABLE QUALITY LEVEL (AQL) IS IDENTIFIED AS 4.0 FOR PRIMARY PACK APPEARANCE OR 0.65 FOR CONTAMINATION. AS THE BATCH SIZE IS OVER (B)(4) PRIMARY UNITS, A SINGLE PRIMARY PACK AFFECTED BY THE CONTAMINATION WOULD BE ACCEPTABLE IN A SAMPLE OF (B)(4) UNITS. NO FURTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS BATCH. THE ALUMINIUM TUBES USED IN THIS BATCH WOULD HAVE BEEN PROVIDED BY SUPPLIER (B)(4). AS IT IS UNLIKELY THAT THE TUBE COULD HAVE BEEN IN THIS CONDITION BEFORE FILLING, CONTACTING THE SUPPLIER WOULD NOT BE NECESSARY. THE SUPPLIER HAS SINCE CEASED TRADING, SO WOULD NOT BE POSSIBLE ANYWAY. IT IS LIKELY THIS IMPERFECTION WOULD HAVE BEEN OBSERVABLE AT THE POINT OF PACKING, SO IS UNLIKELY TO HAVE BEEN PACK. IT IS POSSIBLE TO HAVE BEEN CAUSED AT THE POINT OF PACKING. AS THE SECONDARY PACKAGING IS NOT DAMAGED IT IS UNLIKELY FOR THE DAMAGE TO HAVE BEEN SUSTAINED DURING TRANSIT. THE COMPLAINT WAS ESCALATED TO THE DISTRIBUTION QUALITY TEAM, AND IT WAS IDENTIFIED THE SECONDARY PACKS ARE RELABELLED FOR LOCAL MALAYSIA MARKET. THIS INCLUDES OPENING THE SECONDARY PACK TO INSERT AN INSTRUCTIONS FOR USE (IFU). AS NO NONCONFORMANCE WAS IDENTIFIED DURING THE RELABELLING PROCESS, IT IS MOST LIKELY THAT THE DAMAGE HAS BEEN SUSTAINED DURING THE RELABELLING PROCESS AT THE DISTRIBUTION CENTRE. 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: 1000317571.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS, COMPLAINANT CITY, COMPLAINANT STATE, COMPLAINANT POSTAL CODE, COMPLAINANT PHONE, COMPLAINANT COUNTRY. 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: 1000317571.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A HOLE/LEAKAGE ON ONE UNIT OF COMPANY'S STERILE GEL TUBE AND THE PACKAGING WAS INTACT . THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081227 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 3H00021 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown