BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 9853626 · Received March 19, 2020

    Report

    Report Number
    1018233-2020-01944
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Report Date
    May 4, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741017605
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT IS INCONCLUSIVE. A POTENTIAL ROOT CAUSE COULD BE DUE TO A "BALLOON MOLDING¿. 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: ¿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". 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 PATIENT SAID THE BALLOON ON THE FOLEY DID NOT INFLATE CORRECTLY. SHE SAID THE NURSE TESTED THE BALLOON AND IT ONLY INFLATED ON ONE SIDE. SHE SAID IT CURLED UP INTO A ¿U¿, RISKED INJURY THE BLADDER, AND COULD NOT BE USED.

    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 PATIENT SAID THE BALLOON ON THE FOLEY DID NOT INFLATE CORRECTLY. SHE SAID THE NURSE TESTED THE BALLOON AND IT ONLY INFLATED ON ONE SIDE. SHE SAID IT CURLED UP INTO A ¿U¿, RISKED INJURY THE BLADDER, AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321426 BARDEX® LUBRICATH® FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 0166L20 UNK 00801741017605

    Patients

    Seq Age Sex Outcome Treatment
    1