BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C1950 - UNO OR/SECUREMENT

    MDR report key: 12083398 · Received June 29, 2021

    Report

    Report Number
    3005778470-2021-00228
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 17, 2021
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(4). BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN FOLLOWING: UNO DRAIN FIX S (25/200) STER INT IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1301277 AND MANUFACTURING LOT # 9K04809. THE SECUREMENT WERE PRODUCED, VISUALLY CHECKED UNDER SUBASSEMBLY LOTS 9J00052, 9J03196, 9H03032 ON MACHINE 080 AND THEN PACKED IN PEEL PACKS (POUCH) UNDER LOT 9K04809 IN NOVEMBER 2019. PRODUCT MANUFACTURED ON CENTER C2 ON MACHINE P013, WITH TOTAL LOT AMOUNT 79 800 PCS. LOT # 9K04809 WAS STERILIZED UNDER LOT 2173-6315A AND RELEASED BASED ON THE REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED IN COMPLIANCE WITH SOP-000801. THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULT, PACKAGING OF PRODUCTS RUN ACCORDING TO THE PROCESS INSTRUCTION PI41-017 FOR SUBASSEMBLY PROCESS DRAINFIX. VISUAL INSPECTION OF SECUREMENT PRODUCTS ACC. TO TM-296SK WAS PERFORMED BY QUALITY ASSISTANT ON BEGINNING OF ORDER, ON BEGINNING OF EVERY SHIFT AND AFTER EVERY HOUR. PACKAGING WAS DONE ON MACHINE P013 ACCORDING TO THE PROCESS INSTRUCTION PI41-013 FOR PACKING OF STERILE SECUREMENTS PRODUCTS. DURING PACKING PROCESS FOLLOWING TESTS ARE PERFORMED: BURST TEST TO EVALUATE STRENGTH OF THE WELD, WATER LEAKAGE TEST FOR DETECTION OF HOLES IN PRIMARY PACK, PEEL TEST TO CHECK CORRECT OPENING OF THE SEAL AND 100% VISUAL INSPECTION FOR DETECTION OF ANY DEFECTS ON PACKING. BASED ON THE AVAILABLE RECORD, ALL TESTS WERE PERFORMED, AND ALL RESULTS WERE WITHIN SPECIFICATION. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR AFFECTED LOT AND MALFUNCTION CODE. THIS COMPLAINT IS ASSOCIATED WITH A PREVIOUS EVENT OPENED ON 27TH OF SEPTEMBER 2019. WITHIN THE INVESTIGATION WAS CONFIRMED THAT THE CONTAMINATION HAS SURFACED THROUGH THE PAPER STRUCTURE, BUT THE FIBERS CAN BE SEEN INTACT WITHOUT DEGRADATION OR DISSOLVEMENT FROM THE CONTAMINANT. SPECTRAL ANALYSIS CONFIRMS THAT THE SOURCE OF THE CONTAMINATION IS LOCATED INSIDE THE STERILE BARRIER AND THAT THE CONTAMINATION OCCURRED FROM INSIDE, SPECIFICALLY FROM THE DEVICES HYDROCOLLOID MATERIAL. HYDROCOLLOID MATERIAL IS A PART OF THE DRAIN-FIX DEVICE. THE INVESTIGATION CONFIRMED THAT THE PEEL PAPER OF DRAIN-FIX SECUREMENT DEVICE WAS NOT AFFECTED BY THE CONTAMINANT AND THUS SHOULD HAVE KEPT ITS STERILE BARRIER. BASED ON ABOVE WAS DETERMINED THAT THE ISSUE IS RELATED TO THE HYDROCOLLOID MATERIAL BEHAVIOR AND THE STERILE BARRIER OF DEVICE IS NOT AFFECTED. IT IS A COSMETIC ISSUE ONLY. DURING INVESTIGATION IR-19-025-MIC (VERSION 1.0) WERE IDENTIFIED THREE ROOT CAUSES: RC1 - THERE IS NO BARRIER BETWEEN PAPER AND PRODUCT RC2 - PAPER IS NOT DESIGNED TO BE DURABLE AGAINST POLLUTION/CONTAMINATION FROM THE PRODUCT RC3 - PRODUCTS ARE PLACED IN NOT SUITABLE WAY INTO PEEL PACKS CAPA IS IN PROGRESS AND THEY WERE DETERMINED CAPA ACTIONS: TO IMPLEMENTED CHANGED ASSEMBLY PROCESS OF DRAIN FIX SMALL AND LARGE, NEW TOOL FOR ASSEMBLY TO BE CREATED, DRAWINGS OF DRAIN FIX SMALL AND DRAIN FIX LARGE TO BE UPDATED, TRAINING OF RELEVANT OPERATORS ON NEW VERSIONS OF PI AND DRAWINGS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4), MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 1. (B)(4). (B)(6). 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 BY A FACILITY NURSE, THAT THERE WAS A "GREASE-LIKE SUBSTANCE ON PACKAGING". THE PRODUCT WAS NOT USED ON A PATIENT, NO HARM REPORTED. NO PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS RECEIVED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980227 L3C1950 - UNO OR/SECUREMENT TAPE AND BANDAGE, ADHESIVE KGX UNOMEDICAL S.R.O. 680M 9K04809

    Patients

    Seq Age Sex Outcome Treatment
    1