BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 13963273 · Received March 31, 2022

    Report

    Report Number
    9618003-2022-00356
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Report Date
    March 10, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455124497
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 BATCH RECORD REVIEW: LOT 1K01197 WAS MANUFACTURED ON 10/17/2021, CONVEX 2 PC (WCT) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 30/06/2022 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT. SAP MATERIAL 1161268 AND MANUFACTURING ORDER 1611394. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. COMPLAINT DATA ANALYSIS: ON 30/06/2022, COMPLAINT INVESTIGATOR PERFORMED A SEARCH OF COMPLAINTS INTO DATABASE SYSTEM FOR LOT NUMBER 1K01197. AS A RESULT, A TOTAL OF TWO COMPLAINTS WERE FOUND REPORTED AND ONE RELATED TO THE SAME MALFUNCTION CODE OF THIS INVESTIGATION. RETURNED SAMPLE EVALUATION: TWO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZED, FOR LOTS MANUFACTURED IN CONVEX 2 PC AWC FACILITIES. THE RISK LEVEL BASED ON THE INDIVIDUAL RISK ACCEPTABILITY CRITERIA AND RISK EVALUATION ABOVE IS MEDIUM, MEANING THAT THESE RISKS MAY BE ACCEPTED BUT FURTHER RISK CONTROL MEASURES SHALL BE CONSIDERED IF THEY ARE FEASIBLE AND WILL REDUCE THE RISK FURTHER. RISKS JUDGED MODERATE ARE CONSIDERED ACCEPTABLE BASED ON AN ACCEPTABLE RISK-BENEFIT PROFILE AND MUST BE ASSESSED FOR THE NEED FOR POST MARKET SURVEILLANCE. AFTER UNDERSTANDING THE PROCESS, A BRAINSTORMING TOOL WAS USED TO DETERMINE ALL THE POSSIBLE CAUSES OF THE PROBLEM; THE CAUSE & EFFECT DIAGRAM WAS USED AND AS A RESULT THERE WERE FOUND SEVEN (7) POTENTIAL CAUSES IDENTIFIED. ONE (1) OF THEM WERE DISCARDED, AND SIX (6) WERE CONFIRMED AND RETAINED AS ROOT/PROBABLE CAUSE FOR THE FAILURE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSES FOR WAFER DECENTRALIZED WERE IDENTIFIED AS MANPOWER, METHOD AND MACHINE, SEE THE TABLE BELOW FOR DETAILS: PROBABLE ROOT CAUSE: MANPOWER 1. PROCEDURE NOT FOLLOWED BY MANUFACTURING PERSONNEL WHILE PLACING THE MASS ON LOADING PINS. 2. MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS APPLICABLE. MACHINE 3. PISTONS DEFECTIVE. 4. BASE THREAD OF K TOOL LOADING PIN DEFECTIVE. 5. ELECTRO-VALVE DAMAGED METHOD 6. MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS APPLICABLE. THE CORRECTION ACTION AND PREVENTIVE ACTION PLAN WAS GENERATED TO COVER THE PROBABLE CAUSES, TAKING APPROPRIATE ACTIONS AND MEASURE ITS EFFECTIVENESS. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT WAS APPROVED AND COMPLETE. NO ADDITIONAL ACTION WAS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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 END USER REPORTED THAT THE WAFER HOLE WAS OFF CENTERED PRIOR TO USE IN THIRTY WAFERS. THE END USER DID VISUALLY INSPECT THE WAFERS. SHE FURTHER REPORTED THAT SOME OPENINGS WERE OFF-CENTERED MORE THAN OTHERS. THE END USER FURTHER ADDED THAT SHE HAD A MAJOR ABDOMINAL SURGERY AND WAS IN THE HOSPITAL FOR A MONTH AND HAD A VERY SLOW RECOVERY AND ENDED UP BACK IN THE HOSPITAL FOR A COUPLE OF DAYS AND HAD MANY OF DOCTORS APPOINTMENTS. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345555 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413179 1K01197 00768455124497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown