BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 10825670 · Received November 11, 2020

    Report

    Report Number
    3005778470-2020-00212
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    October 26, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 4 OF 4. (B)(6). DISTRIBUTOR: (B)(4). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THE PHOTO OF AFFECTED PRODUCT WAS RECEIVED AND INSPECTED. THE SAMPLE DID NOT MEET SPECIFICATION. IT SEEMS THAT THE CATHETER WAS SLIGHTLY WELDED INTO THE WELD OF THE POUCH PACKAGE. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATIONS (PR). A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER MANUFACTURING LOT # 9M00025 IN C2. DURING TUBE EXTRUSION PROCESS ROUGHNESS IS MEASURED. THE ROUGHNESS OF BOTH TUBE LOTS USED 9K04641 AND 9L04455 WAS UNDER UPPER LIMIT RDC = 3 AND RA = 0,7. THE CATHETERS WERE PACKED IN PEEL PACKS (POUCH) UNDER LOT 9M00025 IN DECEMBER 2019 ON PACKAGING MACHINE P009. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905704. LOT 9M00025 WAS STERILIZED UNDER STERILIZATION LOT 26 191206,25 191210, 25 191207, 24 191207, 26 191207, 25A191207. DURING PACKAGING IN- PROCESS INSPECTION THE TEST WITH FOCUS ON CATHETERS SQUEEZED IN WELDING WAS CARRIED OUT ACCORDING TO TESTING METHODS (TM) FOR VISUAL INSPECTION OF WELDING CATHETERS IN PEEL PACK: PROCEDURE 3.1 HOLD SAMPLE AT GOOD VISUAL DISTANCE. 3.2 ENSURE ADEQUATE LIGHTING IN INSPECTION AREA. 3.3 LOOK AT ENTIRE PEEL PACK SHEET IF THERE IS NO WELDING CATHETERS 3.4 NO WELDING CATHETERS ARE ALLOWED. THE ENTIRE PEEL PACK SHEET IS HELD UP TO CHECK THAT ALL CATHETERS ¿DROP DOWN ¿IN THE PACK. 3.5 WELDING CATHETERS INSIDE PEEL PACK HAVE TO BE DISCARDED RESULT OF THE INSPECTION IS RECORDED IN FORM G905704. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED .DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED. NO NONCONFORMITY RELATED TO THE ISSUE REPORTED HAD BEEN REGISTERED DURING THE PACKAGING PROCESS OF THE MENTIONED LOT. PHOTO WAS RECEIVED TO THE COMPLAINT AND REPORTED ISSUE WAS CONFIRMED. SEVERAL COMPLAINTS OF THIS NATURE WERE RECEIVED IN THE PAST AND THE ISSUE WAS INVESTIGATED WITHIN NON -CONFORMANCE (NC) EVENT. THE ROOT CAUSE INVESTIGATION ASSOCIATED WITH RELATED NON-CONFORMANCE EVENT HAS BEEN APPROVED AND IS COMPLETE. FIVE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED DURING THE INVESTIGATION AND ADDRESSED WITHIN CORRECTIVE/PREVENTATIVE ACTION (CAPA). RC1: CAVITY IS NOT SPACIOUS ENOUGH TO COMPENSATE SMALL DEVIATIONS IN SHAPE. RC2: NOT DEFINED STORING OF THE CATHETERS IN BOXES . THERE IS DEFINITION IN PROCEDURE FOR CORRECT CATHETERS STORING IN BOXES. IN PRODUCTION DATE OF COMPLAINED CATHETERS THERE WAS EFFECTIVE PROCEDURE, WITH NO EXACTLY DEFINITION OF CATHETERS STORING. CC1: EXTRUSION PRODUCTION PROCESS AND BOBBIN CONSTRUCTION. IT IS STANDARD PROCESS, SO IT WILL BE EXCLUDED FROM CAPA PLAN. CC2: NEGLECT OF THE OPERATOR. RC3: NOT PROPER METHOD DEFINED IN THE PROCEDURE RC4: ANY MACHINE DETECTION FOR CATHETER PLACEMENT. RC5: ANY MACHINE DETECTION FOR CATHETER SQUEEZING IN WELD. THIS ROOT CAUSES WERE ADDRESSED WITHIN CAPA. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: DEFINITION OF CORRECT WATER SACHET PLACEMENT TO THE CAVITY IN WORK INSTRUCTION G905704. ORDER OF GUIDES FOR PACKING MACHINE P009 AND INSTALLATION THEM. UPDATE OF WORK MARCH 6TH, 2020. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THE LOT IN QUESTION WAS PRODUCED BEFORE ALL CORRECTIVE ACTION¿S IMPLEMENTATION. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "THE SURFACE OF THE CATHETER IS ROUGH". A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS RECEIVED. THE PRODUCT WAS NOT USED, AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289589 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421566 9M00025

    Patients

    Seq Age Sex Outcome Treatment
    1