BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 16590181 · Received March 22, 2023

    Report

    Report Number
    1018233-2023-01936
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 20, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741045875
    PMA / PMN Number
    K070582
    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, SUPPLIER MANUFACTURING RELATED. SIX EXTENSION CORDS WERE RETURNED WITHOUT THE ORIGINAL PACKAGING. PHOTO SAMPLES WERE SUBMITTED. HOWEVER, COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. NO DAMAGE TO THE CORD WAS NOTED DURING EVALUATION OF THE PHYSICAL SAMPLE. CONNECTIONS OF THE CORD TO THE PLUG AND SOCKET WERE SECURE. USING A MULTIMETER, THE CORDS WERE TESTED FOR AND FOUND TO HAVE CONTINUITY. CORD 1 WAS CONNECTED TO AN IN-HOUSE TEMPERATURE SENSING CATHETER SUBMERGED IN A WATER BATH AT 37 DEGREES C, THE CORD WAS THEN ATTACHED TO A KILO DEVICE AND THE TEMPERATURE DISPLAYED ERRATICALLY FROM NO READING, AND RANGED FROM 36.1 C TO 37.0C. THOUGH THE TEMPERATURE DISPLAYED ERRATICALLY, THE SAMPLE MEETS THE SPECIFICATION "PLUG AND JACK MUST BE FIRMLY SECURED TO WIRE.". USING A CALIPER THE CABLE WAS MEASURED AND THE TIP AND INDENTATION DIAMETER WERE FOUND TO BE OUT OF SPECIFICATIONS; AS THE OUT OF SPECIFICATION MEASUREMENTS CONFIRMED TO NOT BE A CAUSE OF ERRATIC DISPLAY. AS THE CABLE IS SUPPLIED BY WONIK CORPORATION U.S.A., LTD. (F.K.A INTERNATIONAL IMPORTERS) THIS EVENT WILL BE CONFIRMED SUPPLIER RELATED. CORDS 2, 3, 4, 5, AND 6 WERE CONNECTED TO AN IN-HOUSE TEMPERATURE SENSING CATHETER SUBMERGED IN A WATER BATH AT 37 DEGREES, THE CORD WAS THEN ATTACHED TO A KILO DEVICE AND THE TEMPERATURE DISPLAYED 37.3C, 37.2, 37.2C, 371.1C AND 37.2C RESPECTIVELY, SIMILAR TO THE THERMOMETER READING. A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE OPERATOR ERROR. THE DEVICE WAS USED FOR DIAGNOSTIC PURPOSES. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABEL/PACK REVIEW IS NOT REQUIRED AS A REVIEW OF THE LABEL COULD NOT HAVE PREVENTED THE REPORTED EVENT. CORRECTIONS: A, F, H. 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 EVALUATED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPERATURE DISPLAY DISAPPEARED, OR TEMPERATURE WAS DISPLAYED LOWER THAN ACTUAL AFTER 35 DAYS OF USE. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 01 MAR 2023, IT WAS REPORTED THAT THE DURING EVALUATION, THE DIMENSIONS OF THE CABLE PLUG WERE FOUND TO BE OUT OF SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPERATURE DISPLAY DISAPPEARED, OR TEMPERATURE WAS DISPLAYED LOWER THAN ACTUAL AFTER 35 DAYS OF USE. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON (B)(6)2023 , IT WAS REPORTED THAT THE DURING EVALUATION, THE DIMENSIONS OF THE CABLE PLUG WERE FOUND TO BE OUT OF SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436957 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 UNK 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other