BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER

    MDR report key: 10671446 · Received October 13, 2020

    Report

    Report Number
    1018233-2020-20099
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 14, 2020
    Report Date
    January 12, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    PMA / PMN Number
    K984084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE, "HIGH MODULUS SILICONE". 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: ¿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 INFL ATE WITH STATED ML OF STERILE WATER. OR ¿ FOR PRE-FI LLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFL ATE 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 RESTERILIZE CONSULT INSTRUCTIONS FOR USE. 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 FOLEY CATHETER BALLOON WAS UNABLE TO INFLATE WHILE USING IN THE SURGERY THERAPY. THE SURGEON USED A THIRD FOLEY CATHETER WHICH SEEMS TO BE WORKING FINE.

    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 FOLEY CATHETER BALLOON WAS UNABLE TO INFLATE WHILE USING IN THE SURGERY THERAPY. THE SURGEON USED A THIRD FOLEY CATHETER WHICH SEEMS TO BE WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138275 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 NGDX4214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other