BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® HEMATURIA FOLEY CATHETER

    MDR report key: 9226843 · Received October 23, 2019

    Report

    Report Number
    1018233-2019-06725
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 6, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741025167
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING-RELATED. THE EVALUATION OF THE HEMATURIA CATHETER PHOTO SAMPLE SHOWED THAT THE INFLATION CAP APPEARED TO BE ATTACHED AT ABOUT A 45-DEGREE ANGLE. THE ROOT CAUSE OF THIS FAILURE IS MACHINE MALFUNCTION DURING THE RETAINER CAP ASSEMBLY PROCESS DUE TO WHICH THE CAP WAS APPLIED CROOKED ONTO THE INFLATION FUNNEL, RESULTING IN USER INCONVENIENCE AND REPLACEMENT OF DEVICE. 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: ¿RELEASED PEEL TO OPEN C. R. BARD, INC. COVINGTON, GA 30014 WWW.BARDMEDICAL.COM 1-800-526-4455 BARDEX® FOLEY CATHETER CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. PD-50201 10/00 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. BARD AND BARDEX ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLUE CAP WAS FOUND SLANTED UPON USE. THERE WAS NO LEAKAGE OBSERVED.

    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 BLUE CAP WAS FOUND SLANTED UPON USE. THERE WAS NO LEAKAGE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025422 BARDEX® LUBRICATH® HEMATURIA FOLEY CATHETER HEMATURIA 3-WAY KOD C.R. BARD, INC. (COVINGTON) -1018233 2551H24 NGCV0924 00801741025167

    Patients

    Seq Age Sex Outcome Treatment
    1