BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 21773470 · Received April 4, 2025

    Report

    Report Number
    1018233-2025-02353
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 14, 2025
    Report Date
    June 5, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    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 BECAUSE NO SAMPLE WAS RETURNED. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/ EXPOSURE TO PETROLATUM BASED PRODUCTS/ MECHANICAL FAILURE/OPERATOR ERROR). A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. 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 UROFORCE FOLEY CATHETER BALLOON POPPED INPATIENT. DOCTOR WAS USING IT OFF LABEL FOR URETERAL DILATION NOT URETERAL, HOWEVER IT SHOULD NOT HAVE POPPED. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UROFORCE FOLEY CATHETER BALLOON POPPED INPATIENT. DOCTOR WAS USING IT OFF LABEL FOR URETERAL DILATION NOT URETERAL, HOWEVER IT SHOULD NOT HAVE POPPED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371959 UNKNOWN LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other