BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 20727954 · Received November 19, 2024

    Report

    Report Number
    3005778470-2024-01052
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Report Date
    November 14, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    UDI-DI
    30768455143550
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E.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. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. THE PROCESS PARAMETERS WERE ADJUSTED WITHIN THE VALIDATED WINDOW. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT AND OF THE MENTIONED ISSUE. NO COMPLAINT WAS RECEIVED ON LOT# 4A05391 AND THIS TYPE OF ISSUE. ACCORDING TO G805311 V. 28.0, SEC. 5.12.4. VISUAL AND TACTILE CHECK OF EYELETS ¿ NO THREADS AND/OR FRAYED EDGES, SLUGS/ PUNCH OUTS ARE ALLOWED AND EYELETS HAVE TO BE SMOOTH. CHECK OF EYELETS IS PROVIDED ACCORDING TO TM-356, VER.3.0 AND TESTS RESULTS HAVE BEEN RECORDED IN G905311 FORM 3. THE PERCENTAGE OF AFFECTED PIECES AGAINST LOT IS (B)(4). THIS COMPLAINT WAS PRESENTED TO THE COMPLAINT REVIEW BOARD ON DECEMBER 12, 2024. THIS IS CONSIDERED AN ISOLATED ISSUE. ATTENDEES DECIDED THAT NO FURTHER ACTION ARE REQUIRED. OPERATORS WILL BE RETRAINED ACCORDING TO G708002 EDUCATION AND TRAINING OF PRODUCTION PERSONNEL AND THE ISSUE WILL BE PRESENTED TO OPERATORS ACCORDING TO (B)(4) QA DATA VISUALIZATION. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. 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

    END USER REPORTED HE HAS BEEN CATHING SINCE 2012 FOLLOWING DIAGNOSIS OF BPH AND A TURP SURGERY. HE REPORTED HE PLACED ONE CATHETER AND IT HURT MORE THAN NORMAL AND HE TOOK IT OUT, RAN HIS FINGERS DOWN IT AND SAID WHEN HE RAN HIS FINGERS BY THE TIP, BY THE EYELETS AREA "IT FELT REALLY PRETTY ROUGH" LIKE THEY WEREN'T POLISHED WELL. HE SAID HE PREPPED IT PROPERLY AND SAID AS HE JUST STARTED EXAMINING THE CATHETERS IN THE BOX AND HE ESTIMATES ABOUT HALF CATHETERS IN THE BOX WERE LIKE THAT. HE SAID THEY FELT ROUGH BY EYELETS PRIOR TO BURSTING WATER SACHET AND AFTER. HE DISCARDED THEM.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069744 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421569 4A05391 30768455143550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male