BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18675532 · Received February 9, 2024

    Report

    Report Number
    3005778470-2024-00516
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Report Date
    February 8, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A2: AGE: 70, SEX: MALE 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 AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION AND STERILIZATION PROCESS OF THE MENTIONED LOT. ONE SIMILAR COMPLAINT WAS RECEIVED FOR THIS LOT. COMPLAINT WAS SUBMITTED TO COMPLAINT REVIEW BOARD HELD ON 29TH OF FEBRUARY 2024. (B)(4). BASED ON INCREASED TREND OF RECEIVED COMPLAINTS WAS OPENED NEW CAPA#: 1832524 INCREASED COMPLAINT TREND RELATED TO THE ISSUE PEELPACK PAPER TEARING UNEVENLY WHEN OPENING GENTLECATH GLIDE. CAPA OPENED 20/FEB/2024 AND IT IS IN INVESTIGATION STATE. 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 STATES "HE FEELS THE ADHESIVE ALONG THE SIDES OF THE PACKAGING THAT SEALS THE PAPER AND PLASTIC TOGETHER IS TOO STRONG. HE SAID HE NEVER HAD TROUBLE PEELING THEM OPEN IN THE PAST, HE SAID NOW TO GET IT TO PEEL IT OPEN HE HAS TO PULL MUCH HARDER THAN HE EVER HAS; HAS TO HOLD IT WITH BOTH THUMBS ON THE VINYL AND PULL DOWN THE PAPER AND THE PAPER WILL TEAR DOWN THE MIDDLE STICKING TO THE SIDES WHERE ADHESIVE IS. HE THEN HAS TO GRAB A KNIFE TO BE ABLE TO "SCORE THE PAPER AWAY" TO GET THE CATHETER OUT WHICH COULD EASILY CONTAMINATE THE CATHETER AS HE SAID HE DOES NOT SANITIZE THE KNIFE PRIOR AND IT DOES TOUCH THE WATER THE CATHETER IT SITTING IN." END USER WAS ADVISED TO AVOID USING A CATHETER HE FEELS COULD BE CONTAMINATED PRIOR TO USE.

    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
    52066 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421910 3C04450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown