BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 17887142 · Received October 6, 2023

    Report

    Report Number
    1018233-2023-07230
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 14, 2023
    Report Date
    January 31, 2024
    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. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED, CAUSE UNKNOWN. TWELVE EXTENSION CORD WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. A POTENTIAL ROOT CAUSE FOR THIS FAILURE IS "WRONG DIMENSIONS ON COMPETITORS OR OUR OWN CONNECTOR" OR "USER DAMAGED PINS WHEN INSERTING CONNECTOR". 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 (119118 LOT NGEVZ327) AT 37 DEGREES, 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.". THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: " FOR USE WITH BARD TEMPERATURE-SENSING PRODUCTS AND ACCESSORIES". 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 THE TEMPERATURE DISPLAY BECAME UNSTABLE DUE TO A POSSIBLE CONNECTION PROBLEM WITH THE MONITOR. THE REPRESENTATIVE COULD NOT CONFIRM THE NUMBER BUT CONFIRMED 13 BLACK CABLES, WHERE 12 ARE CASE BULL TYPE 153622. ONE BOTTLE WAS CONFIRMED TO BE J-SOL. 13 CHECKED FOR THE APPEARANCE OF THE CABLES BUT COULD NOT CONFIRM. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2023, THE CUSTOMER CLARIFIED THAT TOTAL 12 CABLES WERE AFFECTED AND THERE WAS AN ANOTHER PRODUCT MIXED WITH THE 12 CABLES ALREADY REPORTED. THEY CLARIFIED THAT THERE WAS NO FITTING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPERATURE DISPLAY BECAME UNSTABLE DUE TO A POSSIBLE CONNECTION PROBLEM WITH THE MONITOR. THE REPRESENTATIVE COULD NOT CONFIRM THE NUMBER BUT CONFIRMED 13 BLACK CABLES, WHERE 12 ARE CASE BULL TYPE 153622. ONE BOTTLE WAS CONFIRMED TO BE J-SOL. 13 CHECKED FOR THE APPEARANCE OF THE CABLES BUT COULD NOT CONFIRM. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22SEP2023, THE CUSTOMER CLARIFIED THAT TOTAL 12 CABLES WERE AFFECTED AND THERE WAS AN ANOTHER PRODUCT MIXED WITH THE 12 CABLES ALREADY REPORTED. THEY CLARIFIED THAT THERE WAS NO FITTING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341801 BARD® EXTENSION CABLE EXTENSION CABLE EZL C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other