BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA FOLEY CATHETER SILICONE COATED

    MDR report key: 11046045 · Received December 21, 2020

    Report

    Report Number
    1018233-2020-21864
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 4, 2020
    Report Date
    May 19, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE, MANUFACTURING RELATED DUE TO OPERATOR ERROR/ MECHANICAL ERROR/USER RELATED/MISHANDLING PRODUCT/THIN RUBBERIZED LAYER. RECEIVED ONLY CATHETER CUT AT INFLATION FUNNEL. SAMPLE HAS BEEN EVALUATED AND OBSERVE THERE WAS NO ABNORMALITIES ON RETURNED CATHETER. INFLATED CATHETER WITH LAB SYRINGE AND CATHETER CAN BE INFLATE AND DEFLATE WITHOUT DIFFICULTIES. THERE WAS NO DENT ON THE SURFACE OF RETURNED CATHETER. HOWEVER, A COMPLETE EVALUATION COULD NOT BE PERFORMED DUE TO POOR IN PHYSICAL SAMPLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. ¿ USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR ¿ FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. DO NOT USE IF PACKAGE IS DAMAGED. BARD, BARDEX, BARDIA, BIOCATH AND LUBRICATH ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. SINGLE USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE CONSULT INSTRUCTIONS FOR USE. BD SWITZERLAND SÀRL TERRE BONNE PARK ¿ A4 (B)(4), SWITZERLAND C. R. BARD, INC. COVINGTON, GA 30014 USA 1 800 526 4455 WWW.BARDMEDICAL.COM MANUFACTURER: TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. 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, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT 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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 DURING THE FOLEY CATHETER INSERTION, AN ALLEGED RESISTANCE WAS NOTED WHILE INFLATING THE BALLOON. WHILE ATTEMPTING TO DEFLATE THE BALLOON, THE FLUID WOULD ALLEGEDLY NOT RETURN AND THE FOLEY CATHETER WAS UNABLE TO REMOVE. IT WAS FURTHER REPORTED THAT THE STAFF TRIED CUTTING THE FLUID CHANNEL TO RELEASE THE FLUID WITH NO SUCCESS. LATER, A METAL STYLET WAS INSERTED INTO THE FOLEY CATHETER AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE BALLOON ALLEGEDLY HAD NO FLUID WHEN IT WAS REMOVED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FOLEY CATHETER INSERTION, AN ALLEGED RESISTANCE WAS NOTED WHILE INFLATING THE BALLOON. WHILE ATTEMPTING TO DEFLATE THE BALLOON, THE FLUID WOULD ALLEGEDLY NOT RETURN AND THE FOLEY CATHETER WAS UNABLE TO REMOVE. IT WAS FURTHER REPORTED THAT THE STAFF TRIED CUTTING THE FLUID CHANNEL TO RELEASE THE FLUID WITH NO SUCCESS. LATER, A METAL STYLET WAS INSERTED INTO THE FOLEY CATHETER AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE BALLOON ALLEGEDLY HAD NO FLUID WHEN IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516060 BARDIA FOLEY CATHETER SILICONE COATED FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 MYCPR988

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention