BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 22235492 · Received June 17, 2025

    Report

    Report Number
    1018233-2025-04676
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 28, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USE FOR UROLOGICAL CARE. A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE DUE TO USER RELATED (EXAMPLE: UNDER-INFLATION DURING USE)/ ASSEMBLY OF THE BALLOON TO THE SHAFT/ UNEVEN THICKNESS OF BALLOON. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO PROGRAM ERROR-PLC FAULTY WHICH CAUSED CATHETER FALLS OUT AFTER INITIAL PLACEMENT. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. UNABLE TO REVIEW THE LABELLING DUE TO UNKNOWN PRODUCT CODE. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE FOLEY CATHETER IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2025, DUE TO URETHRAL STRICTURE AND HAD AN INDWELLING FOLEY CATHETER. THE CATHETER WAS SECURED AND FUNCTIONING WELL, BUT IT CAME OUT ON ITS OWN WHEN THE PATIENT GOT OUT OF BED. THE DOCTOR WAS IMMEDIATELY NOTIFIED TO CHECK THE PATIENT, AND IT WAS FOUND THAT THE CATHETER BALLOON WAS INTACT AND THERE WAS NO DAMAGE TO THE URETHRAL OPENING. THE PATIENT CONDITION WILL CONTINUE TO BE MONITORED. NO SPECIAL TREATMENT WAS GIVEN, AND THE PATIENT CONTINUED TO OBSERVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2025, DUE TO URETHRAL STRICTURE AND HAD AN INDWELLING FOLEY CATHETER. THE CATHETER WAS SECURED AND FUNCTIONING WELL, BUT IT CAME OUT ON ITS OWN WHEN THE PATIENT GOT OUT OF BED. THE DOCTOR WAS IMMEDIATELY NOTIFIED TO CHECK THE PATIENT, AND IT WAS FOUND THAT THE CATHETER BALLOON WAS INTACT AND THERE WAS NO DAMAGE TO THE URETHRAL OPENING. THE PATIENT CONDITION WILL CONTINUE TO BE MONITORED. NO SPECIAL TREATMENT WAS GIVEN, AND THE PATIENT CONTINUED TO OBSERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21830 UNKNOWN LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other