BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

    MDR report key: 17510642 · Received August 11, 2023

    Report

    Report Number
    1018233-2023-06040
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 6, 2023
    Report Date
    November 6, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741046322
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED MANUFACTURING RELATED. 1SAMPLE WERE CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED FOLEY CATHETER ATTACHED TO THE DRAINAGE BAG. VISUAL INSPECTION OF THE SAMPLE NOTED FOREIGN MATERIAL AT THE TIP OF THE CATHETER. THIS DOES NOT MEET SPECIFICATION WHICH STATES THAT "PRODUCT /ASSEMBLY MUST BE FREE FROM VISIBLE LOOSE OR EMBEDDED FOREIGN MATTER". A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE ¿NO FOLLOW UP TO CLEANING PROCEDURE IN THE PRODUCTION AREAS". THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿BARDEX® I.C ANTI-INFECTIVE FOLEY CATHETER WITH BARD® HYDROGEL AND BACTI-GUARD® SILVER ALLOY COATING INFECTION CONTROL FOLEY CATHETER SERIES 400 WITH TEMPERATURE SENSOR CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX THAT CAN CAUSE ALLERGIC REACTIONS. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY REPRESENT A POTENTIAL BIOHAZARD. PLEASE HANDLE AND DISPOSE OF IT ACCORDINGLY WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY TO OR ON THE ORDER OF A PHYSICIAN. CAUTION: DO NOT ASPIRATE URINE THROUGH THE WALL OF THE DRAIN FUNNEL. STERILE UNLESS THE PACKAGE IS OPENED OR DAMAGED. FOR SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. VALVE TYPE: USE LUER-SLIP SYRINGE, DO NOT USE NEEDLE. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH THE CDC'S "GUIDELINE FOR THE PREVENTION OF OF CATHETER-ASSOCIATED URINARY TRACT INFECTION." AT ONSET OR EARLY SIGNS FROM A URINARY TRACT INFECTION, CATHETER FOULING, OR ANY OTHER CATHETER-RELATED ADVERSE EFFECT, THE CATHETER SHOULD BE REPLACED. TO DEFLATE THE CATHETER BALLOON: GENTLY INSERT A LUER-SLIP TIP SYRINGE INTO THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS NECESSARY TO MAKE THE SYRINGE "STICK" IN THE VALVE. ALLOW THE PRESSURE INSIDE THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE. WITH WATER. IF YOU NOTICE THAT DEFLATION IS SLOW OR DOES NOT DEFLATE, CAREFULLY RESEAT THE SYRINGE. USE ONLY A GENTLE SUCTION TO STIMULATE DEFLATION IF NECESSARY. VIGOROUS ASPIRATION IT CAN COLLAPSE THE INFLATION LUMEN, PREVENTING THE BALLOON FROM DEFLATING. IF THE PROTOCOL ALLOWS FROM THE HOSPITAL, THE VALVE ARM MAY IF THIS FAILS, CONTACT A PROFESSIONAL PROPERLY TRAINED TO OBTAIN HELP, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURES, CARE MUST BE TAKEN TO ENSURE THAT THE REMOVED ALL THE BALLOON FRAGMENTS FROM THE PATIENT. VISUALLY INSPECT PRODUCT FOR SURFACE BLEMISHES OR DETERIORATION BEFORE USING IT. NOTE: COMPATIBLE WITH APPROPRIATE TEMPERATURE MONITORS FROM THE 400 SERIES. INTERCHANGEABILITY + 0.2 °C AT 37 °C. AS WITH ALL TEMPERATURE PROBES, IN THE PRESENCE OF SOURCES OF RADIO FREQUENCY ENERGY, LOCAL HEATING, ERRORS MAY OCCUR OF TEMPERATURE AND DAMAGE TO THE PROBE. IN MEDICAL USE, UNPLUG THE CATHETER TEMPERATURE SENSOR ON THE TEMPERATURE MONITOR BEFORE ACTIVATING ELECTROSURGICAL OR OTHER TYPES OF DIRECT COUPLED RF ENERGY SOURCES. DO NOT STRETCH THE CATHETER, AS THIS WILL CAUSE THE PROBE REPOSITIONING. DO NOT USE THE STYLET, AS THIS WILL CAUSE THE CATHETER TO STRETCH RECOMMENDED INFLATION CAPACITIES 5CC BALLOON: USE 10CC OF STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES.¿ 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "NO FOLLOW UP TO CLEANING PROCEDURE IN THE PRODUCTION AREAS." IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE PROVIDED LOT NUMBER WAS INVALID THEREFORE DHR REVIEW CAN¿T BE COMPLETED. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    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 FOLEY CATHETER HAD BLACK DEBRIS AT THE END OF THE FOLEY TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER HAD BLACK DEBRIS AT THE END OF THE FOLEY TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER HAD BLACK DEBRIS AT THE END OF THE FOLEY TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117065 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741046322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other