BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIHESIVE

    MDR report key: 18666487 · Received February 8, 2024

    Report

    Report Number
    9618003-2024-00082
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Report Date
    January 15, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: ¿ NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 3C04849 WAS MANUFACTURED ON 31 MAR 2023, IN (B)(4), WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 31/JAN/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) 1103432 AND MANUFACTURING ORDER (B)(4). THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION (PI31-136) AND RECORDED IN BR31-136. 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 31/JAN/2024, THE COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR 3C04849 LOT FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ AND AS RESULT NO ADDITIONAL TYPE 2 COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 31/JAN/2024, THE COMPLAINT 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)¿ FOR THE LOT NUMBER 3C04849 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 OF 18,900 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.005% WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE 0.25% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP) "QUALITY INSPECTION PLAN". IN ADDITION, ALL 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 THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: NO OBJECTIVE EVIDENCE WAS RECEIVED SUCH AS A PHOTO OR SAMPLE, FOR THIS REASON, WE CANNOT CONCLUDE THAT THE PRODUCT DOES NOT MEET SPECIFICATIONS. THE REVIEW OF THE BATCH RECORD 3C04849 SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS, ALL APPLICABLE MANUFACTURING AND QUALITY PROCESSES WERE FOLLOWED, AND NO DISCREPANCIES OR DEVIATIONS WERE RECORDED. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR LOT AFFECTED RELATED TO THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿. BASED ON THIS, NO NEGATIVE TREND WAS IDENTIFIED. BASED ON PRELIMINARY INVESTIGATION RESULTS, THERE IS NO OBJECTIVE EVIDENCE THAT OTHER PRODUCTS FROM THIS LOT ARE IMPACTED. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. 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: 9618003

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PHARMACIST THAT IT WAS DIFFICULT TO REMOVE THE DRESSING FROM SKIN AND THAT CAUSED PAIN. THE PRODUCT WAS USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159182 VARIHESIVE DRESSING, WOUND, OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187905 3C04849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown