BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE CATH

    MDR report key: 10641703 · Received October 7, 2020

    Report

    Report Number
    3005778470-2020-00191
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Report Date
    September 22, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). THE PHOTO OF THE AFFECTED PRODUCT WAS RECEIVED AND INSPECTED. THE SAMPLES DID NOT MEET SPECIFICATION. ON THE CATHETER IS VISIBLE TRACE FROM WELDING. THE CATHETER WAS SLIGHTLY CAUGHT TO THE PEELPACK AND VERY LIKELY WAS RELEASED FROM THE PEELPACK WELD DURING OPENING. THE MARK OF CATHETER BEING WELDED IN PEELPACK WELD IS VISIBLE IN THE PROVIDED PICTURE. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION PR60-215 . A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP REF CODE 1718779 AND MANUFACTURING LOT #0A02667 IN C2. THE CATHETERS WERE PACKED IN PEELPACKS (POUCH) UNDER LOT LOT 0A02667 IN JANUARY 2020 ON PACKAGING MACHINE P009. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905704. LOT 0A02667 WAS STERILIZED UNDER STERILIZATION LOT 24 200125. DURING IN- PROCESS INSPECTION TEST WITH FOCUS ON CATHETERS SQUEEZED IN WELDING IS CARRIED OUT ACCORDING TO TM-437 VISUAL INSPECTION OF WELDING CATHETERS IN PEELPACK : PROCEDURE 3.1 HOLD SAMPLE AT GOOD VISUAL DISTANCE 3.2 ENSURE ADEQUATE LIGHTING IN INSPECTION AREA. 3.3 LOOK AT ENTIRE PEELPACK SHEET IF THERE IS NO WELDING CATHETERS 3.4 NO WELDING CATHETERS ARE ALLOWED. THE ENTIRE PEELPACK SHEET IS HELD UP TO CHECK THAT ALL CATHETERS ¿DROP DOWN¿ IN THE PACK 3.5 WELDING CATHETERS INSIDE PEELPACK HAVE TO BE DISCARDED RESULT OF THE INSPECTION IS RECORDED IN FORM G905704 REVIEW OF THE 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. SEVERAL COMPLAINTS OF THIS NATURE WERE RECEIVED IN THE PAST AND THE ISSUE WAS INVESTIGATED WITHIN NC EVENT TW # 1181258. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT TW # 1181258 HAS BEEN APPROVED AND IS COMPLETE. FIVE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED DURING THE INVESTIGATION AND ADDRESSED WITHIN 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 ACTUALLY. 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 WAS 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 1216197. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: 1:DEFINITION OF CORRECT WATER SACHET PLACEMENT TO THE CAVITY IN WORK INSTRUCTION G905704. 2: ORDER OF GUIDES FOR PACKING MACHINE P009 AND INSTALLATION THEM. 3. UPDATE OF WORK INSTRUCTIONS G905704, G905718 THE LOT IN QUESTION WAS PRODUCED BEFORE IMPLEMENTING ALL CORRECTIVE ACTIONS MENTIONED ABOVE. 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.

    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. 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 "CATHETER WITH DRY GLUE STUCK ON IT.¿ AN OUTBOUND FOLLOW-UP CALL TO THE CONSUMER WAS PERFORMED AND THE CONSUMER STATED, ¿YOU SENT ME REPLACEMENTS AND I PULLED OUT ONE (1) CATHETER THAT HAS THE SAME ISSUE WITH GLUE ON IT, THE PACKAGE WAS STUCK TO THE CATHETER.¿ THE ISSUE WAS NOTED PRIOR TO USE, NO HARM REPORTED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110542 GENTLE CATH CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421912 0A02667

    Patients

    Seq Age Sex Outcome Treatment
    1