BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 9977647 · Received April 20, 2020

    Report

    Report Number
    3005778470-2020-00106
    Event Type
    Malfunction
    Date Received
    April 20, 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 · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6). (B)(6). THE PHOTO OF AFFECTED PRODUCT WAS RECEIVED AND INSPECTED. THE SAMPLES DID NOT MEET SPECIFICATION. THE CATHETER TIP IS FLAT. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION PR60-107 VER 4.0. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1718756 AND MANUFACTURING LOT # 8F03499 IN C2. THE CATHETERS WERE PACKED IN PEELPACKS (POUCH) UNDER LOT LOT 8F03499 FROM 25-26 JUNE 2018 ON PACKAGING MACHINE P009. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905704. LOT 8F03499 WAS STERILIZED UNDER STERILIZATION LOT 24 180629, 24 180630 25 180630 25 180701, 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. PHOTO WAS RECEIVED TO THE COMPLAINT AND REPORTED ISSUE WAS CONFIRMED. THERE WAS VISIBLE TRACES OD PEELPACK WELD ON THE CATHETER SURFACE. THE CATHETER WAS CAUGHT IN THE WELD WHAT DAMAGED ITS SURFACE CAUSING ITS DAMAGE. SEVERAL COMPLAINTS OF THIS NATURE WERE RECEIVED IN THE PAST AND THE ISSUE WAS INVESTIGATED WITHIN NC EVENT TW # (B)(4). THE INVESTIGATION ASSOCIATED WITH RELATED EVENT TW # (B)(4) HAS BEEN APPROVED AND IS COMPLETE. FIVE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED DURING THE INVESTIGATION AND WILL BE ADDRESSED IN CAPA PLAN. 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 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 ARE BEING ADDRESSED WITHIN CAPA 1216197. THE FOLLOWING CORRECTIVE ACTIONS ARE BEING 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 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: 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

    DEVICE 4 OF 5. (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER "FOUND THE CATHETER TIP GET FLAT BECAUSE THE TIP IS SEALED TOGETHER WITH POUCH. HOWEVER, HE USED THE CATHETER AND GOT BLOOD DUE TO IT. THE BLOOD LOSS WAS REPORTED TO BE "VERY SMALL". HE WENT TO HOSPITAL FOR TREATMENT". PATIENT RECEIVED ANTIBIOTIC, NAME NOT GIVEN, PATIENT WAS NOT DIAGNOSED WITH AN INFECTION. PHOTOGRAPHS OF THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442774 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421565 8F03499

    Patients

    Seq Age Sex Outcome Treatment
    1