BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 17064424 · Received June 5, 2023

    Report

    Report Number
    3005778470-2023-00127
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Report Date
    June 5, 2023
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    UDI-DI
    30768455143574
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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: (B)(4). MANUFACTURING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    NO PICTURE OR SAMPLE WAS PROVIDED. THE ISSUE ON THE PRODUCT IS DETECTABLE DURING PRODUCTION. 100% VISUAL INSPECTION WITH FOCUS ON THE ISSUE IS CARRIED OUT. REVIEW OF THE DHR LOT 1K02603 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. DURING COMPLAINT REVIEW, THE INCREASED NUMBER OF COMPLAINTS RELATED TO THE ISSUE - CATHETER SQUEEZED IN WELDING PACKAGING, HAS BEEN OBSERVED. CAPA TW (B)(4) HAS BEEN OPEN TO INVESTIGATE THE ISSUE. WITHIN THE CAPA AS IMMEDIATE ACTION OPERATORS WERE RETRAINED ON VISUAL INSPECTION THAT IS FOCUSED ON THE REPORTED DEFECT. WAS DETERMINED THAT CPM SLIGHTLY INCREASED, BUT THE INCIDENCE OF DEFECT OCCURRENCE IS NOT HIGH. NO HARM WAS REPORTED. THE CORRECTIVE ACTION IMPLEMENTED PREVIOUSLY, THAT COVERED IMPLEMENTATION OF GUIDES UNDER CCR-DMR-00059, DID NOT ENSURE 100% HELP TO HOLD CATHETERS ON THE RIGHT PLACE IN THE CAVITIES. ONLY REDUCE POTENTIAL RISK OF CATHETERS SQUEEZING IN WELD. NO ANOTHER COMPLAINT HAS BEEN RECEIVED ON THE LOT. THE DEFECT RATES SHOULD BE (B)(4) BASED ON G805118 GENERAL QUALITY REQUIREMENTS, CLASS A1 NONCONFORMITIES -WELDING MUST BE INTACT ALL THE WAY ROUND. FOR 1K02603 -- THE DEFECT RATE IS 1 UNIT REPORTED OUT OF PRODUCED (B)(4) PCS UNITS EQUIVALENTS TO (B)(4). NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. 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 "THE CATHETER TIP IS WELDED WITH PACKAGE SEALING."

    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
    1093912 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421571 1K02603 30768455143574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown