BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C1950 - UNO OR/SECUREMENT

    MDR report key: 12606562 · Received October 11, 2021

    Report

    Report Number
    3005778470-2021-00481
    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

    LOT # 1C03888 WAS STERILIZED UNDER LOT 2173-18674A 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, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAS BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOT. NO OTHER SIMILAR COMPLAINT WAS RECEIVED ON THE LOT 1C03888 AND 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)¿. SAMPLE OF PRODUCT WITH FOREIGN BODY WAS INVESTIGATED AND IT WAS FOUND THAT IT IS A PAPER PART OF NAPKIN. COMPLAINT ISSUE IS RELATED TO INVESTIGATION (B)(4). BASED ON THE INVESTIGATION IT WAS FOUND THAT PRODUCT WAS PACKED IN THE COVID19 SEASON, WHEN WAS IDENTIFIED LACK OF SINGLE-USE CAPS & COATS SUPPLIES. IN THE MENTIONED SEASON IT WAS DECIDED TO EXTEND ALLOWED USAGE OF SINGLE-USE PROTECTIVE EQUIPMENT AS CAPS AND COATS USED IN MANUFACTURING AREA AFTER ENTERING CLEAN ZONE. ALSO, THIS EQUIPMENT WAS DECIDED TO SEPARATE, SEND FOR CLEANING AND DISINFECTING IN ORDER TO ALLOW MULTIPLE USAGE. THIS RISK WAS TAKEN UPON TO INCREASED DEMAND OF MEDICAL SUPPLIES ON THE MARKET IN ORDER TO SATISFY CUSTOMERS¿ NEEDS AND PREVENT MISSING IMPORTANT MEDICAL SUPPLIES ON THE MARKET, HOSPITALS, END USERS. THE ACTION WAS INTRODUCED ON MARCH 18, 2020. FROM THIS REASON THERE IS NOT REQUIRED TO IMPLEMENT ANY FURTHER CORRECTIVE/PREVENTIVE ACTIONS DUE TO THIS ISOLATED CASE DUE TO COVID19 PANDEMIC. IN THE COVID 19 SEASON IS AN INCREASED NEED FOR CLEANING OF ALL MANUFACTURING SPACE. DURING CLEANING ARE USED PAPER NAPKIN AND 70% IPA. PART OF NAPKIN COULD HAVE FALLEN INTO THE BOX WITH PRODUCTS. THIS COULD BE THE CAUSE OF A FOREIGN BODY IN THE PEELPACK. INVESTIGATION (B)(4) IS VALID FOR ALL PACKING MACHINES AND WHOLE PACKING PROCESS OF PRODUCTS. INVESTIGATION REPORT IR_21-008-MIC(V1) WAS APPROVED. CRB HELD ON 30/NOV/2021 DECIDED, THAT NO FOLLOW ACTION IS REQUIRED. BASED ON THE INVESTIGATION RESULTS THE ISSUE IS CONSIDERED TO BE ISOLATED. WE WILL MONITOR IF THERE IS RISING TREND OF COMPLAINTS RELATED TO THE ISSUE IN QUESTION. 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
    1502847 L3C1950 - UNO OR/SECUREMENT TAPE AND BANDAGE, ADHESIVE KGX UNOMEDICAL S.R.O. 680M 1C03888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown