BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRICATH FOLEY CATHETER

    MDR report key: 12174647 · Received July 15, 2021

    Report

    Report Number
    1018233-2021-04240
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    June 20, 2021
    Report Date
    September 23, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    PMA / PMN Number
    K922431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. BASED ON THE EVALUATION, WATER WAS ABLE TO BE INTRODUCED INTO THE INFLATION LUMEN WITHOUT ANY BLOCKAGE. HOWEVER, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO POOR CONDITION OF THE SAMPLE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE)/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE. 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: "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." CORRECTIONS: D, H. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE OF POOR SAMPLE CONDITION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. BASED ON THE EVALUATION, WATER WAS ABLE TO BE INTRODUCED INTO THE INFLATION LUMEN WITHOUT ANY BLOCKAGE. HOWEVER, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO POOR CONDITION OF THE SAMPLE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE)/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE. 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: "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 BARD 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 BARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATTEMPT IN DEFLATING THE BALLOON WAS NOT SUCCESSFUL BY THE COMPLAINANT. UROLOGY REVIEWED THAT IT WAS UNABLE TO REMOVE THE BALLOON USING A GUIDE WIRE. HENCE THE PATIENT HAD TO VISIT SOUTH COAST RADIOLOGY THIS MORNING FOR ANOTHER POPPING OF THE BALLOON. BESIDES VISITING SOUTH COAST RADIOLOGY FOR PROCEDURE- NO HARM TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATTEMPT IN DEFLATING THE BALLOON WAS NOT SUCCESSFUL BY THE COMPLAINANT. ALSO UROLOGY REVIEW UNABLE TO REMOVE THE BALLOON USING A GUIDE WIRE. HENCE THE PATIENT HAD TO VISIT SOUTH COAST RADIOLOGY THIS MORNING FOR ANOTHER POPPING OF THE BALLOON. BESIDES VISITING SOUTH COAST RADIOLOGY FOR PROCEDURE- NO HARM TO PATIENT.

    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 ATTEMPT IN DEFLATING THE BALLOON WAS NOT SUCCESSFUL BY THE COMPLAINANT. ALSO UROLOGY REVIEW UNABLE TO REMOVE THE BALLOON USING A GUIDE WIRE. HENCE THE PATIENT HAD TO VISIT SOUTH COAST RADIOLOGY THIS MORNING FOR ANOTHER POPPING OF THE BALLOON. BESIDES VISITING SOUTH COAST RADIOLOGY FOR PROCEDURE- NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068545 BARDEX LUBRICATH FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 MYEU1975

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention