BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C3850 - GENTLECATH

    MDR report key: 11107568 · Received January 4, 2021

    Report

    Report Number
    3005778470-2020-00239
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    December 18, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINED THAT THE THIEMANN INDICATOR HAD NOT BEEN LINED UP WITH EYELETS. THIS IS NOT IN ACCORDANCE WITH REQUIREMENTS. THE TIEMANN INDICATOR SHOULD BE ALIGNED UP WITH THE CURVED TIP. PHOTO WAS RECEIVED BUT IT IS HARD TO EVALUATE POSITION OF CONNECTOR INDICATOR AGAINST BENT TIP OF CATHETER BASED ON THE PICTURE. BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN FOLLOWING: WHOLE PRODUCTION AND PACKAGING PROCESS HAS BEEN DONE IN COMPLIANCE WITH PR60-215 MALE COUDE (TIEMANN) CATHETERS ¿ GENTLECATH LOW-FRICTION THE URINARY CATHETERS WAS MANUFACTURED UNDER SAP MATERIAL ID 1718777 AND MANUFACTURING LOT #0B03471. LOT #0B03471 WAS STERILIZED UNDER STERILIZATION BATCH- 26A200302,25A200303, 24 200303, 25 200303, 24A200303, 26A200303 AND RELEASED BASED ON THE REVIEW OF RESULTS OF STERILIZATION. LOT # 0B03471WAS PACKED IN PEEL PACKS ON FEBRUARY 27 ¿ 29 2020 IN CENTER C2 ON PACKAGING MACHINE P009, TOTAL LOT AMOUNT 96.000 PCS. THE CATHETERS WERE ASSEMBLED UNDER SUBASSEMBLY LOTS 0B03468 AND 0B02569 AT MACHINE A097 IN ACCORDING TO THE PROCESS INSTRUCTIONS G805311 VER 13.0. ACCORDING TO THE PROCESS INSTRUCTIONS G805311 VER 13.0 THE POSITION OF CONNECTOR INDICATOR AGAINST BENT TIP OF CATHETER IS CHECKED BY TECHNICIAN DURING ORDER SET UP- 2PCS FROM EACH MOULDING STATION AND VISUAL INSPECTION WITH FOCUS ON TIEMMAN INDICATOR POSITION WAS CARRIED OUT BY OPERATORS AT THE BEGINNING OF EACH SHIFT ACCORDING TO TM-422. ACCORDING TO RELEVANT DRAWING 60099 THE POSITION OF CONNECTOR INDICATOR VS TIP BENDING COULD BE IN THE RANGE 0°- 45° IN BOTH DIRECTIONS. THE CUSTOMER COMPLAINED THAT THE THIEMANN INDICATOR HAD NOT BEEN LINED UP WITH EYELETS. THIS IS NOT IN ACCORDANCE WITH REQUIREMENTS. THE TIEMANN INDICATOR SHOULD BE ALIGNED UP WITH WITH THE CURVED TIP. REVIEW OF THE DHR 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 OF THIS NATURE HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOTS .THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. MACHINE A097 HAD VISION SYSTEM THAT WAS VALIDATED AT THE TIME THE LOT PRODUCTION. THE KEY POINT FOR INSTALLATION AND SETTING VISION SYSTEM IS TO PROVIDE A CONTROL OF ALL CATHETERS FOCUS ON CATHETERS FAILURE : EYELET NO PUNCH, HANGNAIL LEFT IN EYELETS, POSITION OF CONNECTOR INDICATOR AND BENT TIP OF CATHETER, VISION SYSTEM HAS TO REJECT EVERY CATHETER WITH AT LEAST OF ONE FAILURES MENTIONED ABOVE . VALIDATION OF THE POSITION OF TIEMANN INDICATOR WAS IN SCOPE CCR-01239. CCR-01239 WAS SIGN ON DECEMBER 19TH 2019. LOT IN QUESTION WAS PRODUCED BEFORE VALIDATION OF THE CAMERA. NO OTHER COMPAINT OF THIS NATUURE HAS BEEN RECEIVED ON THIS LOT. 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 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 BY THE PRODUCT END USER THAT " THE FUNNEL SHOULD BE LINED UP WITH THE EYELETS ON THE TIP OF THE CATHETER AS A GUIDE FOR INSERTION, BUT HE HAS NOTICED SOME ARE OUT OF ALIGNMENT ANYWHERE FROM 10 TO 30 DEGREES". HE HAS BEEN ABLE TO USE THEM WITHOUT A PROBLEM, NO HARM REPORTED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE SUBMITTED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3721 L3C3850 - GENTLECATH GBM UNOMEDICAL S.R.O. 421910 0B03471

    Patients

    Seq Age Sex Outcome Treatment
    1