BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 22060319 · Received May 21, 2025

    Report

    Report Number
    1018233-2025-03706
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 2, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741095092
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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. VISUAL INSPECTION NOTED BOTH CATHETER WAS 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 NO ABNORMALITIES OBSERVED INSIDE 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 REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON BURST. DO NOT ASPIRATE URINE THROUGH THE DRAINAGE FUNNEL WALL. SINGLE PATIENT USE ONLY. DO NOT REUSE AND RESTERILIZE. FOR UROLOGICAL USE ONLY. USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN. IF PERMITTED BY HOSPITAL PROTOCOL, THE MAY BE CUT OFF. IF THIS FAILS, CONTACT AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. CORRECTION- D, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 BEFORE THE PACKAGE WAS OPENED THE TIP OF FOLEY CATHETER WAS APPARENTLY SHOWN BROKEN AND THE PRODUCT WAS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE THE PACKAGE WAS OPENED THE TIP OF FOLEY CATHETER WAS APPARENTLY SHOWN BROKEN AND THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937121 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 MYGP2896 00801741095092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other