BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER

    MDR report key: 18355631 · Received December 19, 2023

    Report

    Report Number
    1018233-2023-09038
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 27, 2023
    Report Date
    March 12, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741029721
    PMA / PMN Number
    K821745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED - CAUSE UNKNOWN. RECEIVED TWO (2) PHOTO SAMPLES. BOTH PHOTO SAMPLES SHOWCASE AN OVERVIEW OF A 2-WAY CATHETER. VISUAL INSPECTION NOTED NO DEFECTS OR ABRASIONS ON THE CATHETER. THE CATHETER BALLOON WAS INFLATED WITH 5 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND IT SLOWLY LEAKED OUT OF THE INFLATION VALVE. FURTHER INSPECTION UPON REMOVAL OF INFLATION CAP REVEALED A CRACK ON THE INFLATION VALVE. THIS IS OUT OF SPECIFICATION WHICH STATES, CATHETER LEAKS, VALVE LEAKS, BALLOON PERFORATION, LUMEN TO LUMEN, PREMATURELY DEFLATED AND DISLODGED BALLOON ARE NOT ALLOWED, AND MUST INFLATE AND DEFLATE WITH THE USE OF A SYRINGE." A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE INCORRECT MOLDING OF EITHER THE INFLATION VALVE OR RETENTION CAP. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: "RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5ML STERILE WATER 5CC BALLOON: USE 10ML STERILE WATER 30CC BALLOON: USE 35ML 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. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. BARD AND BARDEX ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. 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 DETERIORATION PRIOR TO USE." SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE INFLATION VALVE OF THE FOLEY CATHETER DURING STERILE WATER INJECTION. NO ABNORMALITY WAS FOUND IN THE VALVE. NO ABNORMALITIES WERE DETECTED THROUGHOUT THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE INFLATION VALVE OF THE FOLEY CATHETER DURING STERILE WATER INJECTION. NO ABNORMALITY WAS FOUND IN THE VALVE. NO ABNORMALITIES WERE DETECTED THROUGHOUT THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484742 BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 NGGX0147 00801741029721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other