BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C1950 - UNO OR/SECUREMENT

    MDR report key: 12608692 · Received October 11, 2021

    Report

    Report Number
    3005778470-2021-00483
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Report Date
    October 6, 2021
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 2 CASE. THE IDENTIFIED 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) IS ASSOCIATED WITH GOLDEN INVESTIGATION (B)(4). PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS COMPLAINT, WHICH WERE EVALUATED IN ACCORDANCE WITH (B)(4). IT IS VISIBLE FOREIGN BODY/ MARKS INSIDE PRIMARY PACK. IT WAS RECEIVED 1PC OF SAMPLE TO SIMILAR COMPLAINT (B)(4) FOR THE SAME LOT 0K01974. SAMPLE WAS EVALUATED, ISSUE WAS CONFIRMED. 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: 680M AND MANUFACTURING LOT # 0K01974. THE SECUREMENT WERE PRODUCED, VISUALLY CHECKED UNDER SUBASSEMBLY LOTS 0J00258 FROM 17TH OF SEPTEMBER 2020 TILL 29ND OF SEPTEMBER 2020 AND 0J04006 FROM 29ST OF SEPTEMBER 2020 TILL 16TH OF OCTOBER 2020 ON MANUAL OPERATION STATION C080 AND THEN PACKED INTO THE PEELPACKS (POUCH) UNDER LOT 0K01974 FROM 19TH OF OCTOBER 2020 TILL 21ST OF OCTOBER 2020 ON CENTER C2 ON MACHINE P013, WITH TOTAL LOT AMOUNT (B)(4). 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 (B)(4). 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. DURING PRODUCTION OF THIS LOT, POUCHES WERE VISUALLY INSPECTED USING: TM-296 ¿ ON BEGINNING OF ORDER IS CHECKED 1 SAMPLE FROM EACH CAVITY. DURING IN-PROCESS CONTROL IS PERFORMED 100% VISUAL INSPECTION. 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)¿. THREE SIMILAR COMPLAINTS WERE REGISTERED ON MENTIONED MALFUNCTION CODE: (B)(4). IT WAS RECEIVED 1PC OF SAMPLE FOR SIMILAR COMPLAINT (B)(4), WHICH WAS INVESTIGATED. DURING PRODUCTION OF LOT 0K01974 WAS USED PACKING RAW MATERIAL: PACKING FOIL SAP CODE (B)(4) 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 (B)(4)¿ FOREIGN BODY. 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 (B)(4) FOREIGN BODY- SECUREMENTS (UNO DRAIN FIX S 25/200 STER INT) WAS APPROVED AT CRB-C5/QA/WH-MIC HELD ON 26-APR-2021 BY MEETING ATTENDANTS. CORRECTIVE AND PREVENTIVE ACTIONS ARE COVERED WITHIN CAPA TW1454179 FOREIGN BODY- SECUREMENTS OPENED ON 04TH OF MAY 2021. CAPA IS IN EFFECTIVENESS CHECK STATE AND THEY WERE DETERMINED CAPA ACTIONS: CA1: IMPLEMENTATION OF CHAIN COVERING AT THE PLACE NEXT TO FILM FEEDING. CA2: INCLUDING C5 TECHNICIANS INTO G805121. CA3: UPDATE TM-296/TM-296SK. EC1: PRODUCTION OF 3 BATCHES AFTER IMPLEMENTATION OF SUGGESTED SOLUTION. EC2: REVIEW OF COMPLAINTS 6 MONTH AFTER IMPLEMENTATION. ALL CORRECTIVE ACTIONS WERE IMPLEMENTED. THE CHAIN COVERING WAS INSTALLED AT THE PLACE NEXT TO FILM FEEDING FROM (B)(6) 2021. LOT 0K01974 WAS MANUFACTURED BEFORE IMPLEMENTATION OF CORRECTIVE ACTIONS. THE INVESTIGATION OF ISSUE WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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:3005778470.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER COMPLAINANT CONTACT INFORMATION: (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. FDA REGISTRATION NUMBER REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "THAT THERE IS A FOREIGN MATTER AT THE INSIDE OF THE PACKAGE." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503345 L3C1950 - UNO OR/SECUREMENT TAPE AND BANDAGE, ADHESIVE KGX UNOMEDICAL S.R.O. 680M 0K01974

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown