BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 13125594 · Received December 31, 2021

    Report

    Report Number
    1018233-2021-08628
    Event Type
    Malfunction
    Date Received
    December 31, 2021
    Date of Event
    December 16, 2021
    Report Date
    April 8, 2022
    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 WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. A TEMPERATURE SENSING CATHETER EXTENSION CORD WAS RETURNED OPENED WITHOUT ORIGINAL PACKAGING. A PHOTO SAMPLE WAS ALSO RETURNED. NO DAMAGE TO THE CORD WAS NOTED. UNABLE TO DETERMINE IF THE CABLE HAD TEMPERATURE DISPLAY ISSUES FROM THE PHOTO SO THE PHYSICAL SAMPLE WAS EVALUATED. NO DAMAGE TO THE CORD WAS NOTED. CONNECTIONS OF THE CORD TO THE PLUG AND SOCKET WERE SECURE. USING A MULTIMETER, THE CORD WAS TESTED FOR AND FOUND TO HAVE CONTINUITY. THE CORD WAS CONNECTED TO AN IN-HOUSE TEMPERATURE SENSING CATHETER SUBMERGED IN A WATER BATH (119118 LOT NGEVZ327) THE CORD WAS THEN ATTACHED TO A KILO DEVICE AND WAS ABLE TO DISPLAY THE TEMPERATURE. TEMPERATURE DISPLAYED WAS SLIGHTLY HIGHER THAN THE THERMOMETER TEMPERATURE. PER PRODUCT QE, THIS DIFFERENCE WOULD NOT BE INDICATIVE OF A FAILURE. THE SAMPLE MEETS THE SPECIFICATION "PLUG AND JACK MUST BE FIRMLY SECURED TO WIRE". THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE DEVICE WAS USED FOR DIAGNOSTIC PURPOSES. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED

    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 A SLIGHT TOUCH CAUSED AN ERRATIC DISPLAY OR A LOW TEMPERATURE DISPLAY. THERE WERE MANY OF THE SIMILAR PROBLEMS SINCE THE 153622-MODEL NUMBER WAS INTRODUCED. THE CUSTOMER COMPLAINED THAT THE STRENGTH OF THE CABLE HAD BEEN REDUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SLIGHT TOUCH CAUSED AN ERRATIC DISPLAY OR A LOW TEMPERATURE DISPLAY. THERE WERE MANY OF THE SIMILAR PROBLEMS SINCE THE 153622-MODEL NUMBER WAS INTRODUCED. THE CUSTOMER COMPLAINED THAT THE STRENGTH OF THE CABLE HAD BEEN REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027932 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 BMFU0001 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other