BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C3850 - GENTLECATH

    MDR report key: 11207163 · Received January 21, 2021

    Report

    Report Number
    3005778470-2021-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    January 7, 2021
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION PR60-112 VER 3 MALE NELATON DEHT. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1706965 AND MANUFACTURING LOT # 0A02726 IN C2 ON PACKAGING MACHINE P011 IN AMOUNT 172 800 PCS IN JANUARY 2020. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905703 PACKAGING PRODUCTS ON PACKAGING MACHINES . LOT 0A02726 WAS STERILIZED UNDER STERILIZATION LOT 24 200122, 25 200123, 24 200124, 26 200125. THE RAW CATHETERS WERE PRODUCED UNDER SUBASSEMBLY LOTS 0A02691, 0A02102. TUBES THAT WERE USED DURING CATHETERS PRODUCTION WERE PRODUCED UNDER LOTS 0A00265, 0A00266, 0A00267. THE VISUAL INSPECTION OF THE EACH TUBE REEL IS A PART OF IN PROCESS INSPECTION. NO DEFECT IS ALLOWED. 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 PROCESS OF THE MENTIONED LOT. NO SAMPLE OR PICTURE WAS PROVIDED. A QUERY WAS RUN AGAINST PART NUMBER ERP MATERIAL NUMBER 1706965 AND MALFUNCTION CODE UCA-PMC07.02 CATHETER SHAFT, BALLOON, TIP OR EYELETS TOO ROUGH, OR TOO SHARP; UCA-PMC7.2 CATHETER SHAFT, BALLOON, TIP OR EYELETS TOO ROUGH, OR TOO SHARP WHICH YIELDED NO ANOTHER OCCURRENCE FROM NOVEMBER 2016. 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 3 OF 10. 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'S WIFE THAT THE END USER THAT THE CATHETERS " FELT ROUGH ON THE OUTSIDE OF THE CATHETER THAT HE FELT WHEN HE INSERTED IT INTO HIS PENIS". THE END USER " CONTINUED TO USE THE CATHETERS" AND AT SOME POINT CONSUMER REPORTED HE "FELT INCREASED PRESSURE IN HIS ABDOMEN". THE END USER NOTIFIED HIS DOCTOR WHO ORDERED A PROPHYLACTIC ANTIBIOTIC TO BE TAKEN ORALLY AND A URINE CULTURE AND SENSITIVITY TEST PERFORMED. HE BEGAN TAKING THE PRESCRIPTION MEDICATION ORALLY WHILE AWAITING THE RESULTS OF THE URINE TEST. THE URINE TEST RESULTS "WERE NEGATIVE FOR URINARY TRACT INFECTION" HE REPORTS THAT HIS DOCTOR HAD HIM FINISH THE COURSE ANTIBIOTICS. HE DID NOT SEE HIS DOCTOR IN OFFICE AS ALL ORDERS WERE DONE OVER THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107541 L3C3850 - GENTLECATH CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 501004 0A02726

    Patients

    Seq Age Sex Outcome Treatment
    1