BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C1950 - UNO OR/SECUREMENT

    MDR report key: 11435137 · Received March 8, 2021

    Report

    Report Number
    3005778470-2021-00108
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    March 3, 2021
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1): CONTACT OFFICE ADDRESS: (B)(6). PHOTOGRAPH AND SAMPLE HAVE BEEN RECEIVED FOR THIS COMPLAINT, WHERE IS VISIBLE FOREIGN BODY/MARKS INSIDE PRIMARY PACK. 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, REF: (B)(4) AND MANUFACTURING LOT # 0K01974. THE SECUREMENT WERE PRODUCED, VISUALLY CHECKED UNDER SUBASSEMBLY LOTS 0J00258 FROM (B)(6) 2020 TILL (B)(6) 2020 AND 0J04006 FROM (B)(6) 2020 TILL (B)(6) 2020 ON MANUAL OPERATION STATION C080 AND THEN PACKED INTO THE PEELPACKS (POUCH) UNDER LOT 0K01974 FROM (B)(6) 2020 TILL 21ST OF (B)(6) 2020 ON CENTER C2 ON MACHINE P013, WITH TOTAL LOT AMOUNT 67 200 PCS. LOT # 0K01974 WAS STERILIZED UNDER CERTIFICATE 2173 ¿ 14751A 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. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. THE PROCESS PARAMETERS WERE ADJUSTED WITHIN THE VALIDATED WINDOW. THE PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION PI41-013 FOR PACKING OF STERILE SECUREMENTS PRODUCTS AND RECORDED IN BR41-013. NO NONCONFORMANCE HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT AND OF THE MENTION MALFUNCTION CODE¿ SEC-PMC07.09 FOREIGN MATTER (E.G. HAIRS, INSECTS) WITHIN PRIMARY PACK (STERILE PRODUCTS-NIKO-FIX, EPI-FIX, EASI V, DRAIN-FIX, CENTRAL GARD ONLY)¿. ONE SIMILAR COMPLAINT WAS REGISTERED ON MENTIONED MALFUNCTION CODE FOR LAST 6 MONTH, BUT DIFFERENT LOT NUMBER: TW1422793. DURING PRODUCTION OF LOT 0K01974 WAS USED PACKING RAW MATERIAL: PACKING FOIL SAP CODE 1725214 WITH BATCH NUMBERS 0001642562 AND 0001623177. INCOMING INSPECTION FOR MATERIAL 1725214 WITH BATCH NUMBERS 0001642562 AND 0001623177 WERE IN ACCORDANCE WITH MATERIAL SPECIFICATION MT58-005 V.4.0. MATERIALS WERE RELEASED BASED ON CONTROL OF CERTIFICATES. CERTIFICATES WERE REVIEWED AND THEY WERE IN ACCORDANCE WITH MT58-005 V.4.0. THIS COMPLAINT IS WITHIN SCOPE OF INVESTIGATION EVENT TW#1442723 - FOREIGN BODY - SECUREMENT (UNO DRAIN FIX S 25/200 STER INT). THE MOST PROBABLE ROOT CAUSE RESULTED FROM THE INVESTIGATION IR21-007-MIC (VER.1) WERE IDENTIFIED: RC1: NOT BARRIER BETWEEN THE CHAIN AND THE FILM. RC2: THE INSTRUCTION DOES NOT CONTAIN THE CLEANING PERIODICITY. RC3: INATTENTION OF THE OPERATORS. INVESTIGATION REPORT IR 21-007-MIC (VER.1)/TW1442723 WAS APPROVED AT CRB-C5/QA/WH-MIC HELD ON (B)(6) 2021 BY MEETING ATTENDANTS. CAPA WILL BE OPEN. BASED ON THE INVESTIGATION RESULTS THE ISSUE IS CONSIDERED TO BE ISOLATED. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT TW1441688 HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS 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: (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)(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 THE PRODUCT DISTRIBUTOR THAT THERE WAS A "FOREIGN BODY FOUND ON THE DEVICE". PRODUCT WAS NOT USED, NO HARM REPORTED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE RECEIVED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335345 L3C1950 - UNO OR/SECUREMENT TAPE AND BANDAGE, ADHESIVE KGX UNOMEDICAL S.R.O. 680M 0K01974

    Patients

    Seq Age Sex Outcome Treatment
    1