BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL EXTRA

    MDR report key: 19189182 · Received April 26, 2024

    Report

    Report Number
    1000317571-2024-00035
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 3, 2024
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    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 H10: INVESTIGATION SUMMARY A BATCH RECORD REVIEW WAS COMPLETED, AND NO DISCREPANCIES WERE FOUND. AQUACEL EXTRA 15X15CM 1X5PK STER DE WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1730130 AND MANUFACTURING LOT NUMBER 3G01243 ON 28 JULY 2023. SYSTEM APPLICATION PRODUCT (SAP) IDENTIFIES THE MANUFACTURE DATE AS 06 JULY 2023, BUT THE BATCH RECORD CONFIRMS THE MANUFACTURE DATE IS 28 JULY 2023. LOT # 3G01243 WAS STERILIZED UNDER WORK ORDER (B)(4) AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 3G01243. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. THIS BATCH IS ASSOCIATED WITH PLANNED DEVIATION DATABASE RELATING TO THE USE OF NEWLY VALIDATED LIPPKE BURST TESTERS TO BE USED INSTEAD OF COBHAM BURST TESTERS DUE TO THE HIGHER ACCURACY. THE COBHAM BURST TESTERS ARE PRE-POPULATED IN SOME BATCH RECORDS, SO THE DEVIATION IS IN PLACE TO ALLOW DOCUMENTATION OF THE NEWLY VALIDATED LIPPKE TESTERS. THIS DEVIATION WOULD NOT HAVE IMPACTED OR CAUSED CONTAMINATION. TWO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE, SO HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION (WIS). THE PHOTOGRAPHS CONFIRM THE REPORTED PRODUCT, LOT AND THE COMPLAINT ISSUE WHERE AN AREA OF LIGHT BROWN DISCOLORATION CAN BE SEEN ON THE DRESSING. THE 15X15CM DRESSING HAS AROUND A 3CM BY 4CM AREA OF DISCOLORATION. THE COMPLAINT SAMPLE WAS REQUESTED ON (B)(6) 2024. THE COMPLAINT SAMPLE WAS NOT RECEIVED BY 20TH JUNE 2024, SO INVESTIGATION WAS COMPLETED WITHOUT IT. NO NON-CONFORMANCE WAS REQUIRED FOR THIS ISSUE AS THE MARK ON THE DRESSING IS AFFECTING A SINGLE DRESSING ONLY. IN A BATCH OF THIS SIZE (5760 SECONDARY PACKS), ACCEPTABLE QUALITY LEVEL'S (AQLS) FOR CONTAMINATION WOULD ALLOW 5 DRESSINGS AND REJECT 6 WITH CONTAMINATION IN A SAMPLE OF 315 DRESSINGS AS PER PROCEDURE. ZERO PACKS OF THIS PRODUCT REMAIN IN DCS, SO IF ALL 28,800 PRIMARY DRESSINGS HAVE BEEN EXHAUSTED TO RETURN A SINGLE CONTAMINATED DRESSING, THIS IS MOST LIKELY AN ISOLATED ISSUE. THIS COMPLAINT IDENTIFIES A SINGLE DRESSING AFFECTED, AND AS THE SAMPLE IS NOT AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY WHAT THE DISCOLORATION ON THE DRESSING IS. WITHOUT THE COMPLAINT SAMPLE, IT IS NOT POSSIBLE TO INVESTIGATE FURTHER, BUT THE CONTAMINATION IS MOST LIKELY TO BE EXCESS HYDROFIBRE MATERIAL THAT HAS ACCUMULATED AND LATER FALLEN ONTO THE DRESSING. THE PHARMACEUTICAL MARKETING (PMK) MANUFACTURING LINE INVOLVED HAS AN AUTO PACKER AND NO VISION SYSTEM, SO IT WILL NOT HAVE BEEN POSSIBLE FOR THE CONTAMINATION TO HAVE BEEN IDENTIFIED PRIOR TO FINAL PACKING. THE DRESSING HAS BEEN IDENTIFIED BEFORE USE AND NOT USED, SO HAS NOT POSED A RISK TO PATIENT. 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.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6), COMPLAINANT CITY, COMPLAINANT POSTAL CODE, COMPLAINANT COUNTRY, COMPLAINANT PHONE, NAME OF AFFILIATION. 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

    THE DISTRIBUTOR REPORTED TO THE COMPANY'S SALES REPRESENTATIVE THAT DISCOLORATION WAS DETECTED ON THE PRODUCT WHEN IMMEDIATELY OPENED. THE PRODUCT WAS NOT USED ON THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045418 AQUACEL EXTRA DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420673 3G01243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown