BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 16673439 · Received April 4, 2023

    Report

    Report Number
    1018233-2023-02285
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 10, 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED AS THE REPORTED FAILURE COULD NOT BE REPRODUCED. PHOTO SAMPLES WERE SUBMITTED, HOWEVER, COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. THREE EXTENSION CABLES WERE RETURNED WITHOUT THE ORIGINAL PACKAGING. AS THE REPORTED EVENT IS UNCONFIRMED, A DHR REVIEW IS NOT REQUIRED. AS THE REPORTED EVENT IS UNCONFIRMED, A LABEL/PACKAGING REVIEW IS NOT REQUIRED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEMPERATURE DISPLAYED WAS NOT STABLE. THE MONITOR WAS A NIHON KOHDEN PRODUCT AND WHEN MEASURED USING THE 153622, THE TEMPERATURE VARIED GOING UP AND DOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEMPERATURE DISPLAYED WAS NOT STABLE. THE MONITOR WAS A NIHON KOHDEN PRODUCT AND WHEN MEASURED USING THE 153622, THE TEMPERATURE VARIED GOING UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392675 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 UNK 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other