BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 13120367 · Received December 30, 2021

    Report

    Report Number
    1018233-2021-08577
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 17, 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 INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT WAS 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 COULD BE "WRONG DIMENSIONS ON COMPETITORS OR OUR OWN CONNECTOR". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "FOR USE WITH BARD TEMPERATURE-SENSING PRODUCTS AND ACCESSORIES". THE DEVICE WAS NOT RETURNED

    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
    2019670 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 UNK 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other