BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL SURGICAL

    MDR report key: 17796901 · Received September 22, 2023

    Report

    Report Number
    9618003-2023-06233
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 30, 2023
    Report Date
    August 30, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 2K01673 WAS MANUFACTURED ON 19/OCT/2022, IN SCD LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 25/SEP/2023, 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 ID 1704503 AND MANUFACTURING ORDER (B)(4). THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE APPLICABLE PROCESS INSTRUCTION - PROCESS INSTRUCTIONS FOR MANUAL ASSEMBLY AND PACKAGING - SCD. REVIEW OF THE BATCH RECORDS 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 25/SEP/2023, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE FROM 01/JAN/2022 TO 25/SEP/2023 IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT NUMBER 2K01673 FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ AND AS RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND. HISTORICAL NONCONFORMANCE REVIEW: ON 25/SEP/2023, 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 2K01673 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 HAS ONLY BEEN 8 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF 10,800 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.07% WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR DIFFICULT TO REMOVE - DIFFICULT TO REMOVE ISSUES WHICH SHOULD BE 0.65% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND AN ADHESIVE ISSUES, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.65. 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 SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT FOR THE MALFUNCTION CODE ¿DRESSING/RIBBON/GEL HANDLES INSUFFICIENT WOUND EXUDATE OR DOES NOT RETAIN ABSORBED WOUND EXUDATE¿. 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. 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.

    Additional Manufacturer Narrative · 0

    DEVICE 5 OF 8. E1: NAME OF AFFILIATION: (B)(6). COMPLAINANT CITY: (B)(6). COMPLAINANT STATE/PROVINCE: (B)(6). H6: MEDICAL DEVICE PROBLEM CODE: AS PER THE INFORMATION PROVIDED BY COMPLAINANT, FOR THE ISSUE DRESSING TOO STICKY, THE IMDRF MED. DEV. PROB. CODE A050901 (ADHESIVE TOO STRONG) IS NOT AVAILABLE FOR SELECTION. 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: 9618003.

    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 A NURSE THAT THE DRESSING WAS REALLY STICKY TO THE PATIENTS¿ SKIN, AND IT WAS REALLY DIFFICULT TO REMOVE. ALSO, REPORTED THAT THEY DID NOT USE CLEANSERS / SKIN PROTECTORS, JUST SALINE TO CLEAN THE INCISION. THE DRESSING WAS APPLIED AT THE WARD AFTER TWENTY-FOUR HOURS OF THE INTERVENTION AND THE DRESSING WAS USED FOR FOUR TO SIX DAYS. FOR REMOVAL, DRESSING WAS PULLED FROM ONE CORNER AND TRIED TO TAKE IT OUT. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353523 AQUACEL SURGICAL DRESSING,WOUND,HYDROPHILIC NAC CONVATEC DOMINICAN REPUBLIC INC 420669 2K01673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown