BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 22183421 · Received June 11, 2025

    Report

    Report Number
    1018233-2025-04372
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 4, 2025
    Report Date
    June 26, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. 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). 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD URINARY INCONTINENCE. WHEN THE NURSE PERFORMED CATHETERIZATION AND CHECKED THE FOLEY CATHETER, FOUND A CRACK AT THE BALLOON PART OF THE CATHETER. AFTER INJECTING WATER, SALINE CAME OUT, SO THEY IMMEDIATELY REPLACED THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD URINARY INCONTINENCE. WHEN THE NURSE PERFORMED CATHETERIZATION AND CHECKED THE FOLEY CATHETER, FOUND A CRACK AT THE BALLOON PART OF THE CATHETER. AFTER INJECTING WATER, SALINE CAME OUT, SO SHE IMMEDIATELY REPLACED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87380 UNKNOWN LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other