BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 11549759 · Received March 23, 2021

    Report

    Report Number
    9618003-2021-00420
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    February 26, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D1 CORRECTION: BRAND NAME: L3O0200 - NATURA, COMMON DEVICE NAME: PROTECTOR, OSTOMY, PRODUCT CODE: EXE, MODEL#: 402202, PMA /510(K)#: EXEMPT. G1: CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6). 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

    (B)(4). BATCH RECORD REVIEW RESULTS: LOT 0F00511 WAS MANUFACTURED ON 6/6/2020 IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. ON 21/JUN/2021, COMPLIANCE ENGINEER ID 6053 PERFORMED A BATCH RECORD REVIEW, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER SAP MATERIAL 1052417 AND MANUFACTURING ORDER 1525805. NO ISSUES RELATED TO THE DEFECT WERE FOUND IN THE DOCUMENTATION. IN ADDITION, THE BATCH RECORD OF BULK LOT 0F00512, MANUFACTURED IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WAS REVIEWED AND NO ISSUES WERE FOUND; THE LOTS RAN ACCORDING TO SAP MATERIAL 1102934 AND ALL THE TESTING RESULTS WERE FOUND SATISFACTORY; THE PROCESS CARRIED OUT WAS FOUND ACCORDING TO AND PI21-139. NO ISSUES REGARDING THE FAILURE MODE REPORTED WAS FOUND IN THE DOCUMENTATION. BATCH RECORD REVIEW SUPPORTS THAT NO ISSUES REGARDING THE FAILURE MODE REPORTED WERE IDENTIFIED. RETURNED SAMPLE EVALUATION: NO PHOTO, VIDEO OR UNUSED RETURN SAMPLE WAS RECEIVED FOR EVALUATION. INVESTIGATION CONCLUSION: THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZED, COMPLAINT MALFUNCTION CODES OST-PMC1.8 / 1.18 (SKIN BARRIER STARTER HOLE IS DEFECTIVE, MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), FOR LOTS MANUFACTURED IN CONVEX 2 PC AWC FACILITIES, HAINA D.R. THE HIGHEST SEVERITY RATING REPORTED WAS 4 WHICH IS CONSIDERED SERIOUS. ALSO, 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: PROCEDURE PI21-139 (CONVEX 2PC WAFER SUB ASSEMBLY MACHINE 2, SECTION 7.1.13 ¿ 7.1.14) NOT FOLLOWED BY MANUFACTURING PERSONNEL WHILE PLACING THE MASS ON LOADING PINS. MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS PER TM-017 AND MR21-139. MACHINE: PISTONS DEFECTIVE. BASE THREAD OF K TOOL LOADING PIN DEFECTIVE. ELECTRO-VALVE DAMAGED. METHOD: MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS PER TM-017 AND MR21-139. THE CAPA PLAN (B)(4) WAS GENERATED TO COVER THE PROBABLE CAUSES, TAKING APPROPRIATE ACTIONS AND MEASURE ITS EFFECTIVENESS. 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

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

    Additional Manufacturer Narrative · 1

    DEVICE 3 OF 5. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOLE ON THE BASEPLATE IS NOT CUT CENTRAL AND IT SITS OFF TO ONE SIDE TOO MUCH, WHICH CAUSED LEAKS. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455548 L3O0200 - NATURA EXE CONVATEC DOMINICAN REPUBLIC INC 402202 0F00511

    Patients

    Seq Age Sex Outcome Treatment
    1