BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 13126499 · Received December 31, 2021

    Report

    Report Number
    1018233-2021-08636
    Event Type
    Malfunction
    Date Received
    December 31, 2021
    Date of Event
    December 16, 2021
    Report Date
    June 3, 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 INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. A PHOTO SAMPLE WAS RETURNED OF A TEMPERATURE SENSING CATHETER EXTENSION CORD. NO DAMAGE TO THE CABLE WAS NOTED IN THE PHOTO SAMPLE. UNABLE TO DETERMINE LOSS OF STRENGTH IN SIGNAL OF THE CABLE WITHOUT TESTING OF THE PHYSICAL CABLE. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR DIAGNOSTIC PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE IS "INPUT FEMALE CONNECTOR WEARS OUT". 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: "FOR USE WITH BARD TEMPERATURE-SENSING PRODUCTS AND ACCESSORIES".

    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 (BATCH# BMFU0001). THERE WERE MANY OF THE SIMILAR PROBLEMS SINCE THE 153622-MODEL NUMBER WAS INTRODUCED (BATCH# UNK). 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 (BATCH# BMFU0001). THERE WERE MANY OF THE SIMILAR PROBLEMS SINCE THE 153622-MODEL NUMBER WAS INTRODUCED (BATCH# UNK). THE CUSTOMER COMPLAINED THAT THE STRENGTH OF THE CABLE HAD BEEN REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027970 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 BMFU0001 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other