BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C3850 - GENTLECATH

    MDR report key: 11012828 · Received December 15, 2020

    Report

    Report Number
    3005778470-2020-00232
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    November 30, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE URINARY CATHETERS IN QUESTION WERE PRODUCED IN ACCORDANCE WITH PRODUCT SPECIFICATION PR60-107. NO SAMPLE OR PICTURE WAS RECEIVED. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE URINARY CATHETERS WERE MANUFACTURED UNDER SAP MATERIAL ID 1713715 AND MANUFACTURING LOT # 8L01441 IN AMOUNT 192 000 PCS. THE CATHETERS WERE PACKED IN PEELPACKS (POUCH) IN NOVEMBER 2018 ON PACKAGING MACHINE P009. LOT WAS STERILIZED UNDER STERILE LOTS 26A181114, 24A181116, 24A181120, 24A181115, 25A181116, 26A181119, 26A181115,24A181117,26 181120, 24 181116,26A181116,25A181120, 25 181116, 24A181119, 26A181120, 26 181116,25A181119. THE PACKAGING PROCESS RUN ACCORDING TO THE PROCESS INSTRUCTION G905704 VER 3.0. PEEL TEST OF CATHETERS IS CARRIED OUT ACCORDING TO TM-410 AND G805066. IT IS A PART OF IN PROCESS INSPECTION. 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. THE PACKAGING PAPER OF THE PEELPACK TORE APART WAS INVESTIGATED PREVIOUSLY. PEELPACK PAPER USED FOR PACKING OF GLIDE CATHETERS IS MORE WAXED THEN PAPER USED FOR STANDARD PRODUCTS. THIS IS WHY THE PAPER TENDS TO BE STICKY WITH THE FOIL AND THEREFORE IT COULD CAUSE LITTLE DIFFICULTIES TO OPEN THE PEELPACK AND TABS COULD TEAR. THEN A MODIFICATION OF SEALS ON THE PACKAGING MACHINE P009 WERE IMPLEMENTED WITHIN TW#1177444 TO IMPROVE OPENING OF PEELPACKS. NEW SEALS WERE INSTALLED AND THEN TESTED AND UPON CONFIRMATION OF POSITIVE RESULTS , IMPLEMENTED INTO PRODUCTION IN MARCH 2019. LOT IN QUESTION WAS PRODUCED BEFORE THE SEAL MODIFICATION. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. 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).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DEVICE 15 OF 15. 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 THAT "WHEN HE USES THE FINGER HOLES TO SEPARATE AND OPEN THE PACKAGING THE WHITE PAPER SPLIT AND TORE IN AN UNEVEN PATTERN MAKING IT IMPOSSIBLE TO OPEN THE CATHETERS PACKAGING WITHOUT USING SCISSORS". THE END USER WAS UNABLE TO PROVIDE PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478860 L3C3850 - GENTLECATH CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421568 8LR1441

    Patients

    Seq Age Sex Outcome Treatment
    1