BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 7399308 · Received April 5, 2018

    Report

    Report Number
    3005778470-2018-00013
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 13, 2018
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DEVICE MANUFACUTURE DATE. NO PHYSICAL SAMPLE HAS BEEN RECEIVED. A PHOTOGRAPH HAS BEEN RECEIVED FOR THIS COMPLAINT, WHICH WAS EVALUATED. THE SAMPLE DID NOT MEET SPECIFICATION. CATHETERS SHALL BE FREE FROM EXTRANEOUS MATTER. A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. BASED ON INVESTIGATION RESULTS CARRIED OUT WITHIN A RELATED AND AN INVESTIGATION EVENT THE ONE MOST LIKELY ROOT CAUSES WERE IDENTIFIED: RC1: BURNED FILM RECEIVED FROM SUPPLIER (THE ORIGIN OF FOREIGN MATTER WAS DETERMINED TO BE A SMALL PART OF BURNED FOIL ON THE PEEL PACK). SUPPLIER OF AFFECTED FILM WILL BE CONTACTED AND ASKED TO PERFORM AN INTERNAL ROOT CAUSE ANALYSIS OF THE ISSUE OCCURRENCE. THE INVESTIGATION ASSOCIATED WITH THE RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    BRAND NAME- GENTLECATH INTERMITTENT URINARY CATHETER STRAIGHT CH 12/18 CM. COMMON DEVICE NAME- CATHETER, URETHRAL. PROCODE - KOD. (B)(6). THE 510K# - K172924. 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 THAT "WITHIN ITS BLISTER ONE CATHETER SHOWS TRACES OF DIRT/COLOR." THE DEVICE WAS NOT USED. A PHOTOGRAPH DEPICTING THE REPORTED ISSUE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244041 TBD KOD 2016022 7J02280

    Patients

    Seq Age Sex Outcome Treatment
    1