BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER

    MDR report key: 9701924 · Received February 12, 2020

    Report

    Report Number
    1018233-2020-00992
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 23, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741025198
    PMA / PMN Number
    K922431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO A "PINCHED LUMEN". THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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. ENGLISH WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. UNITS THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. 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 ROUTE DE CRASSIER 17 1262 EYSINS, 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER GOT STUCK IN THE PATIENT'S URETHRA. THE CATHETER WAS REMOVED BY SURGERY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER GOT STUCK IN THE PATIENT'S URETHRA. THE CATHETER WAS REMOVED BY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163169 BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER HEMATURIA FOLEY CATHETERS (POST-OP CATHETER) KOD C.R. BARD, INC. (COVINGTON) -1018233 2557H24 UNK 00801741025198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other