BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX LUBRICATH FOLEY CATHETER TIEMANN MODEL COUDE

    MDR report key: 10685515 · Received October 15, 2020

    Report

    Report Number
    1018233-2020-20174
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 14, 2020
    Report Date
    May 11, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741018138
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING RELATED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED RED RUBBER FOLEY. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THERE IS A TEAR ABOUT 2 INCHES FROM THE BALLOON. HOWEVER, THE CATHETER WAS NOT COMPLETELY BROKEN APART AS THE CATHETER IS HELD TOGETHER BY SMALL FILAMENTS OF MATERIAL. FROM CLEAN THE CUT IS, THE FAILURE SEEMS TO BE DUE TO A BAGGER CUT. THIS DOES NOT MEET THE SPECIFICATION AS THE "COMPONENTS ARE TO BE PRESENT, CORRECT, UNDAMAGED, AND APPROVED BY Q. A." A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OPERATOR ERROR". 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: "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST. CAUTION: DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP TIP SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5ML STERILE WATER 5CC BALLOON: USE 10ML STERILE WATER 15CC BALLOON: USE 20ML STERILE WATER 20CC BALLOON: USE 25ML STERILE WATER 30CC BALLOON: USE 35ML STERILE WATER 40CC BALLOON: USE 45ML STERILE WATER 75CC BALLOON: USE 80ML STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. 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 PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, 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. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS BROKEN THAT CAUSED THE BALLOON TO DEFLATE AND THE CATHETER TO FELL OUT. IT WAS ALSO STATED THAT THE PLASTIC SHEATH REMAINED INTACT ON ONE SIDE OF THE CATHETER THAT PREVENTED THE PIECES OF THE CATHETER FROM BEING RETAINED IN THE BLADDER. AS PER THE FOLLOW-UP INFORMATION RECEIVED ON 18SEP2020, THE PATIENT CONFIRMED THAT NO ADVERSE EFFECT DUE TO THE EVENT.

    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 THE CATHETER WAS BROKEN THAT CAUSED THE BALLOON TO DEFLATE, AND THE CATHETER TO FELL OUT. IT WAS ALSO STATED THAT THE PLASTIC SHEATH REMAINED INTACT ON ONE SIDE OF THE CATHETER THAT PREVENTED THE PIECES OF THE CATHETER FROM BEING RETAINED IN THE BLADDER. AS PER THE FOLLOW-UP INFORMATION RECEIVED ON 18SEP2020, THE PATIENT CONFIRMED THAT NO ADVERSE EFFECT DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150995 BARDEX LUBRICATH FOLEY CATHETER TIEMANN MODEL COUDE FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 0102L18 NGET1050 00801741018138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other