BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX LUBRICATH FOLEY CATHETER

    MDR report key: 10493608 · Received September 4, 2020

    Report

    Report Number
    1018233-2020-05688
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Report Date
    November 2, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741018978
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE FOR THIS EVENT COULD BE, "BURST BALLOONS". A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE, "HIGH MODULUS LATEX". THE LOT NUMBER WAS 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 THE CATHETER. 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. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. FOR UROLOGICAL USE ONLY. DO NOT USE IF PACKAGE IS DAMAGED BARD, BARDEX, AND LUBRICATH ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. SINGLE USE DO NOT RESTERILIZE 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 BULBS ARE NOT DEFLATING, CATHETERS ARE SNAPPING, AND CATHETERS OFTEN BECOME AIR LOCKED AND WON'T DRAIN.

    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 BULBS ARE NOT DEFLATING, CATHETERS ARE SNAPPING, AND CATHETERS OFTEN BECOME AIR LOCKED AND WON'T DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956747 BARDEX LUBRICATH FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 0167L22 UNK 00801741018978

    Patients

    Seq Age Sex Outcome Treatment
    1