BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 22089400 · Received May 27, 2025

    Report

    Report Number
    1018233-2025-03904
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 14, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741095115
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 CONFIRMED - CAUSE UNKNOWN. THE PRODUCT HAD CAUSED THE REPORTED FAILURE. VISUAL INSPECTION NOTED IRREGULAR BURST WITHOUT MISSING PIECES. INTRODUCED WATER INTO THE INFLATION LUMEN AND DID NOT EXPERIENCE ANY OBSTRUCTIONS TO IMPEDE FLOW. MICROSCOPIC EXAMINATION FOUND THERE WAS PRESENT SALT ON THE BALLOON AREA. HOWEVER, THE EXACT CAUSE ON HOW AND WHEN PROBLEM OCCURRED COULD NOT BE DETERMINED. 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 POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE CONTRIBUTE BY HIGH MECHANICAL STABILITY TIME (MST) OF INCOMING LATEX OR COAGULANT DIP 2- DIPPING SPEED TOO SLOW. BASED ON INFORMATION IN THE FMEA, THE RISK OF THIS FAILURE IS MEDIUM. CURRENT CONTROLS IN PLACE ARE ADEQUATE TO MITIGATE THIS FAILURE MODE. A REVIEW OF THE DEVICE LABELING HAS BEEN CONDUCTED FOR INVESTIGATION PURPOSED. THE LABELING AND INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. CORRECTIONS: D, E, H THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. H11: SECTIONS 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 A FEW DAYS AFTER PLACEMENT, THE FOLEY CATHETER BALLOON WAS BROKEN AND WAS REMOVED SPONTANEOUSLY. THEY HAD NOT RECEIVED ANY REPORTS OF ANYTHING BEING LEFT INSIDE THE BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE A FEW DAYS AFTER PLACEMENT, THE FOLEY CATHETER BALLOON WAS BROKEN AND WAS REMOVED SPONTANEOUSLY. THEY HAD NOT RECEIVED ANY REPORTS OF ANYTHING BEING LEFT INSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715051 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 MYJW1712 00801741095115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other