BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG SURGICAL

    MDR report key: 19236053 · Received May 3, 2024

    Report

    Report Number
    9618003-2024-00729
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 12, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    UDI-DI
    00768455124299
    PMA / PMN Number
    K091034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE FOR EVALUATION IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). NO SAMPLES WERE AVAILABLE FOR THIS COMPLAINT, AND THEREFORE IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 2K01670 WAS MANUFACTURED 16 OCT 2022, IN SCD PACKAGING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 19/APR/2024, 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 IDENTIFICATION (ID) 1257875 AND MANUFACTURING ORDER (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 19/APR/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 2K01670 LOT FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 19/APR/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ DEFECT FOR THE LOT NUMBER 2K01670 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION CODE WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE 14000 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.007%, WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE 0.25% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. TO DATE, IT IS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS NO PHOTOGRAPHS OR SAMPLES WERE AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS NOT POSSIBLE TO RAISE AN INVESTIGATION FOR THE ISSUE REPORTED. A BATCH RECORD REVIEW WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. 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

    THE CUSTOMER HCP (HEALTH CARE PROFESSIONAL) REPORTED THE COMPLAINT TO COMPANY'S REPRESENTATIVE THAT AT THE TIME OF REMOVAL OF THE DEVICE IT APPEARED TO BE FUSED WITH THE SKIN. ALTHOUGH REMOVAL WAS VERY DIFFICULT, IT WAS CAUSING PAIN TO THE PATIENT AT THE SITE OF THE OPERATION AND SUFFERING OF THE AFFECTED SKIN. IT DID NOT PROVOKE SKIN OUTCOMES. THE DRESSING WAS PLACED ON A TOTAL SHOULDER ENDOPROSTHESIS (TEP) RIGHT SHOULDER ON (B)(6) 2024 AND WAS REMOVED ON (B)(6) 2024. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421885 AQUACEL AG SURGICAL DRESSING, WOUND, DRUG FRO CONVATEC DOMINICAN REPUBLIC INC 412011 2K01670 00768455124299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose