BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLY CATH 100 SLCON 5CC 16FR

    MDR report key: 18960431 · Received March 22, 2024

    Report

    Report Number
    1282497-2024-00505
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Report Date
    April 30, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FCB
    UDI-DI
    10884521016675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BALLOON RUPTURES 3-4 DAYS AFTER CATHETER INSERTION. PER ADDITIONAL INFORMATION RECEIVED, THERE WEREN'T ANY PIECES MISSING. THE VOLUME OF LIQUID USED TO INFLATE THE BALLOON WAS 5ML. THE LUBRICANT USED WAS THE ONE FROM THE CATHETERIZATION TRAY CODE 85-5037. THE CATHETER WAS REMOVED FROM THE PATIENT BY THE NURSE AT HOME. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892070 FOLY CATH 100 SLCON 5CC 16FR BAG, HEMOSTATIC FCB CARDINAL HEALTH 8887605163 2224845 10884521016675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown