BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C3850 - GENTLECATH

    MDR report key: 12341838 · Received August 19, 2021

    Report

    Report Number
    3005778470-2021-00333
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Report Date
    August 10, 2021
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    00768455145461
    PMA / PMN Number
    K896729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1706963 AND MANUFACTURING LOT # 0L03071 IN C2 ON PACKAGING MACHINE P011 IN AMOUNT 115 200PCS. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905703 PACKAGING PRODUCTS ON PACKAGING MACHINES . ACCORDING TO G905703 WITHIN IN-PROCESS CONTROL SEVERAL TESTS WERE CARRIED OUT: 5.9.3 VISUAL INSPECTION OF PAPER. NO VISUAL IMPURITIES ON PAPER ARE ALLOWED. 5.9.7. PERFORATION TEST ¿ ACCORDING TO RELEVANT TM-437. 5.9.10 PEELTEST. 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 PICTURE RELATED TO THE COMPLAINT WAS RECEIVED BUT NO FIBERS HAVE BEEN SEEN. NO SAMPLES WERE RECEIVED. A QUERY WAS RUN AGAINST PART NUMBER 501003 AND MALFUNCTION UCA-PMC11.10 PRIMARY PACK FRACTURES, CRACKS, TEARS, RIPS OR SHEDS MATERIAL DURING OPENING WHICH YIELDED NO ANOTHER OCCURRENCE FROM NOVEMBER 2016. 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 64 OF 100. CONTACT OFFICE ADDRESS: (B)(4). COMPLAINANT ADDRESS: (B)(6). COMPLAINANT PHONE: (B)(6). FOREIGN: (B)(6). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PRODUCT END USER THAT WHEN HE OPENS THE CATHETERS THEY "SHED FIBRES". THE QUESTION WAS ASKED IF THE FIBERS WERE SHEDDING WHEN THE END USER WAS SEPARATING EACH CATHETER PACKAGE FROM ONE ANOTHER OR WHILE OPENING THE ACTUAL CATHETER ITSELF? PER THE END USER "IT SHEDS FIBERS WHEN HE OPENS THE ACTUAL CATHETER TO USE." THE QUANTITY WAS CONFIRMED MULTIPLE TIMES. NO PHOTOGRAPH RECEIVED FROM THE END USER DEPICTING THE REPORTED COMPLAINT ISSUE. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240873 L3C3850 - GENTLECATH CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 501003 0L03071 00768455145461

    Patients

    Seq Age Sex Outcome Treatment
    1