BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18581183 · Received January 25, 2024

    Report

    Report Number
    3005778470-2024-00289
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    January 23, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO G905704 VER. 23.0 WITHIN IN-PROCESS THE PEELTEST IS CARRIED OUT. POINT 5.11.3 PEELPACK MUST NOT BE SEALED SO STRONG THAT PAPER RESIDUES REMAINED ON THE FOIL OR PAPER TEARS. SEAL SHOULD BE ENOUGH STRONG TO KEEP PAPER AND FOIL TOGETHER WITHOUT ANY IRREGULARITIES. REVIEW OF TEST RESULTS RECORDED WAS CARRIED OUT AND ALL SAMPLES PASSED PEELTEST REQUIREMENTS. 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. SIMILAR COMPLAINTS RECEIVED ON THE LOT IN QUESTION WERE RECORDED WITH PHOTOS PROVIDED. -% AFFECTED PCS AGAINST THE LOT EQUALS (B)(4). THE DEFECT REPORTED IS BELOW THE AQL 0,4. THE INCREASED TREND OF COMPLAINTS, RELATED TO THE POUCH PAPER TEARS UNEVENLY DURING OPENING WAS OBSERVED. THEREFORE, CAPA 1832524 HAS BEEN RAISED TO INVESTIGATE AND ADDRESS THE ISSUE. 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

    A2: SEX: MALE; AGE: (B)(6) YEARS 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    END USER REPORTS "IN HIS RECENT JANUARY ORDER HE SAID AS HE GOES TO PEEL APART THE PACKAGING TO OPEN, THE PAPER TOP TAB IS TEARING OFF. HE THINKS IT IS MAINLY THE PAPER HAS CHANGED SOMEHOW, HE DOES NOT NOTICE ANY DIFFERENCES IN THE PAPER THAT HE CAN TELL BUT NOTES IT TEARS EASILY OR THE GLUE ON THE PACKAGING IS STRONGER CAUSING IT TO TEAR. HE SAID OF THE 3 BOXES HE RECEIVED OF THE SAME LOT, HE HAS TRIED SOME FROM ALL OF THEM AND THEY ARE ALL DOING THE SAME THING OF ALL THAT HE HAS USED. UNSURE HOW MANY HE USED FROM EACH BOX. HE SAID HE REALLY THINKS IT IS THE PAPER THAT HAS CHANGED AS AFTER HE CATHS HE POURS THE WATER OUT OF THE PACKAGE INTO THE SINK TO NOT PUT THE WATER IN THE TRASH CAN AND NOTICES THE ENTIRE BACK OF THE PAPER IS PERMEATED THROUGH. HE SAID IT TAKES ABOUT 4-5 MINUTES FOR THIS PERMEABILITY TO BE SEEN ON THE PAPER, IT IS NOT IMMEDIATE. HE SAID THIS NEVER OCCURRED BEFORE WITH THIS PRODUCT AS HE HAS ALWAYS DONE THIS ROUTINE AFTER CATHING. HE HAS HAD NO HARM IN USING THEM BUT STATES IT IS AN "ANNOYANCE"." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECTIVE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147902 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421910 3C01306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown