BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECUREMENTS

    MDR report key: 9414589 · Received December 5, 2019

    Report

    Report Number
    3005778470-2019-00155
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR: (B)(6). E.3: OCCUPATION: PRODUCT MANAGER. H.4: CORRECTING MANUFACTURE DATE FROM 05/09/2019 TO 05/13/2019. G.4: 510K- EXEMPT. BATCH RECORD REVIEW WAS CONDUCTED. A PHOTOGRAPH WAS RECEIVED ASSOCIATED WITH LOT NUMBER 9E01784. THERE IS A VISIBLE THAT THE PACKAGE WAS SEALING ON THE PRODUCT. UNO DRAIN FIX S (25/200) STER INT IN QUESTION WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCTS MATERIAL IDENTIFICATION 1301277 AND MANUFACTURING LOT NUMBER 9E01784. THE SECUREMENT WAS PRODUCED, VISUALLY CHECKED UNDER SUBASSEMBLY LOTS 9C03595, 9A05098, 9E01107 ON MACHINE C080 AND THEN PACKED IN PEEL PACKS (POUCH) UNDER LOT 9E01784 MAY 2019 ON CENTER C2 ON MACHINE P013, WITH TOTAL LOT AMOUNT 84 000 PIECES. LOT NUMBER 9E01784 WAS STERILIZED UNDER LOT 2173-3444A AND RELEASED BASED ON THE REVIEW OF RESULTS OF STERILIZATION. ALL THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED IN COMPLIANCE WITH STANDARD OPERATING PROCEDURE. THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULT, PACKAGING OF PRODUCTS RUN ACCORDING TO THE PROCESS INSTRUCTION FOR SUBASSEMBLY PROCESS DRAINFIX. A VISUAL INSPECTION OF SECUREMENT PRODUCTS WAS PERFORMED IN ACCORDANCE TO TESTING METHODS AND PERFORMED BY QUALITY ASSISTANT ON BEGINNING OF ORDER, ON BEGINNING OF EVERY SHIFT AND AFTER EVERY HOUR. PACKAGING WAS DONE ON P013 ACCORDING TO THE PROCESS INSTRUCTIONS FOR PACKING OF STERILE SECUREMENT PRODUCTS. DURING THE PACKING PROCESS THE 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 DEVICE HISTORY RECORD 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 OTHER COMPLAINT OF THIS NATURE ON AFFECTED LOT HAS BEEN REGISTERED IN TRACKWISE 8.7. SYSTEM. ALL THE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED AND ANALYZED DURING THE INVESTIGATION. RC1: THE STANDARD FOR PACKAGING DOES NOT INCLUDE INFORMATION FOR CORRECT INSERTING THE PRODUCTS TO THE CAVITIES AS THE RISK FOR PACKAGING WAS NOT CONSIDER ENOUGH. A NON ¿ CONFORMANCE HAS BEEN INITIATED AND WILL REMAIN OPEN UNTIL THE INVESTIGATION ASSOCIATED WITH THE NON- CONFORMANCE IS COMPLETE. 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

    (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. DEVICE 1 OF 1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS NOTED TO HAVE "THE PACKAGE NOT SEALED". A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS SUBMITTED BY THE COMPLAINANT. THE PRODUCT WAS NOT USED ON A PATIENT, NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210278 SECUREMENTS TAPE AND BANDAGE, ADHESIVE KGX UNOMEDICAL S.R.O. 680M 9E01784

    Patients

    Seq Age Sex Outcome Treatment
    1