BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 22234708 · Received June 17, 2025

    Report

    Report Number
    1018233-2025-04672
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    November 11, 2024
    Report Date
    August 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
    PA, 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 FOR EVALUATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. HOWEVER, THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO WRONG PRODUCT SIZE SELECTED. 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 REGISTERED NURSE WAS IN THE PROCESS OF INSERTING A 14FR FOLEY CATHETER. AFTER VISUALIZING URINE RETURN IN THE DRAINAGE TUBE PORTION OF THE CATHETER. THE NURSE BEGAN TO FILL THE BALLOON PORTION. AN OBVIOUS LEAK WAS NOTED JUST PAST THE SAMPLING PORT. A NEW CATHETER WAS OBTAINED, AND THE DAMAGED CATHETER WAS REMOVED AND FOLEY INSERTION WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE REGISTERED NURSE WAS IN THE PROCESS OF INSERTING A 14FR FOLEY CATHETER. AFTER VISUALIZING URINE RETURN IN THE DRAINAGE TUBE PORTION OF THE CATHETER. THE NURSE BEGAN TO FILL THE BALLOON PORTION. AN OBVIOUS LEAK WAS NOTED JUST PAST THE SAMPLING PORT. A NEW CATHETER WAS OBTAINED, AND THE DAMAGED CATHETER WAS REMOVED AND FOLEY INSERTION WAS COMPLETED. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ATTACHMENT ON (B)(6) 2025, IT WAS REPORTED BY THE CUSTOMER STATED THIS OCCURRED WITH A FEW DIFFERENT LOTS. THEY DID NOT HAVE THE NUMBERS CURRENTLY, BUT CUSTOMER DID PROVIDE COUPLE OF LOT NUMBERS TO THEIR REPS WHEN THEY CAME OUT. SECOND INSERTION OF CATHETER TYPE OF MEDICAL INTERVENTION WAS PROVIDED. THE DEVICE WAS NOT REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33857 UNKNOWN LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other