BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

    MDR report key: 8663130 · Received June 3, 2019

    Report

    Report Number
    1018233-2019-02863
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 13, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. THE CATHETER WAS EVALUATED AND DID NOT FIND ANY EVIDENCE OF A FAILURE THAT WOULD SUPPORT THE REPORTED EVENT. 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: "[DIRECTIONS FOR USE] 14) DO NOT STRETCH CATHETER AS DAMAGE TO OR DISLODGEMENT OF LEAD WIRE AS TEMPERATURE PROBE MAY CAUSE IMPROPER TEMPERATURE MEASUREMENT. 15) WHEN ENDOELECTRIC SURGERY IS PERFORMED, CARE SHOULD BE TAKEN TO PREVENT BURNS IN THE LOCAL TISSUE. 16) DO NOT WET THE LEAD WIRE AND THE JUNCTION WITH EXTENSION CABLE. 17) THIS DEVICE IS COMPATIBLE ONLY WITH MONITORS REQUIRING YSI 400-SERIES TYPE TEMPERATURE PROBES." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD WIRE ON THE TEMP SENSING CATHETER WAS FOUND TO BE CRUSHED UPON OPENING THE PACKAGE. THE USER THEN OPENED ANOTHER ONE FROM THE SAME LOT AND FOUND IT TO BE THE SAME. A THIRD CATHETER WAS OPENED AND USED.

    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 LEAD WIRE ON THE TEMP SENSING CATHETER WAS FOUND TO BE CRUSHED UPON OPENING THE PACKAGE. THE USER THEN OPENED ANOTHER ONE FROM THE SAME LOT AND FOUND IT TO BE THE SAME. A THIRD CATHETER WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454965 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER FOLEY CATHETER (LATEX) MJC C.R. BARD, INC. (COVINGTON) -1018233 8PA137

    Patients

    Seq Age Sex Outcome Treatment
    1