BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 22235370 · Received June 17, 2025

    Report

    Report Number
    1018233-2025-04684
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    April 3, 2025
    Report Date
    July 17, 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 AS NO SAMPLE WAS RETURNED FOR EVALUATION. 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. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO OPERATOR ERROR, MECHANICAL FAILURE, USER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A TWO FOLEY REPLACEMENTS WITHIN 24-HOUR PERIOD. THE FIRST FOLEY ATTEMPT (4/2) WAS SUCCESSFUL BUT WAS FOUND LATER TO HAVE A HOLE IN CATHETER BALLOON. CUSTOMER MENTIONED THAT THEY AND ONE OTHER NURSE PUSHED A FLUSH INTO THE CATHETER TO SEE IF THE BALLOON WOULD INFLATE AND DISCOVERED A HOLE IN THE CATHETER BALLOON. THE SECOND ATTEMPT (4/3) THE NEXT DAY THE BALLOON WAS COMPLETELY DEFLATED AND FOUND UNDER PATIENT. CUSTOMER HAD CONTACTED DISTRIBUTION TO OBTAIN A NEW FOLEY SET TO SEE IF THE CURRENT SUPPLY ON THE UNIT WAS DEFECTIVE. THEY CONTACTED OTHER UNITS TO SEE IF SIMILAR PROBLEMS WERE OCCURRING. THE UNITS CONTACTED WERE ED & MEDSURGE. BOTH UNITS SAID THEY HAD NO ISSUES WITH FOLEY CATHETERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A TWO FOLEY REPLACEMENTS WITHIN 24-HOUR PERIOD. THE FIRST FOLEY ATTEMPT (4/2) WAS SUCCESSFUL BUT WAS FOUND LATER TO HAVE A HOLE IN CATHETER BALLOON. CUSTOMER MENTIONED THAT THEY AND ONE OTHER NURSE PUSHED A FLUSH INTO THE CATHETER TO SEE IF THE BALLOON WOULD INFLATE AND DISCOVERED A HOLE IN THE CATHETER BALLOON. THE SECOND ATTEMPT (4/3) THE NEXT DAY THE BALLOON WAS COMPLETELY DEFLATED AND FOUND UNDER PATIENT. CUSTOMER HAD CONTACTED DISTRIBUTION TO OBTAIN A NEW FOLEY SET TO SEE IF THE CURRENT SUPPLY ON THE UNIT WAS DEFECTIVE. THEY CONTACTED OTHER UNITS TO SEE IF SIMILAR PROBLEMS WERE OCCURRING. THE UNITS CONTACTED WERE ED & MEDSURGE. BOTH UNITS SAID THEY HAD NO ISSUES WITH FOLEY CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449618 UNKNOWN LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other