BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SL BASIC TRAY W/SAFETY INTRODUCER

    MDR report key: 19094074 · Received April 11, 2024

    Report

    Report Number
    3006260740-2024-01681
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 13, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741086991
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVAULATION.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. THE COMPLAINT OF THE REUSE OF THE GROSHONG CATHETER IS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. ONE 4 FR S/L GROSHONG NXT CLEARVUE CATHETER ATTACHED TO ITS TWO-PIECE CONNECTOR WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION REVEALED BLOOD USE RESIDUES THROUGHOUT THE RETURNED SAMPLE. THE ENTRY DESCRIPTION DESCRIBES THE REUSE OF THE DEVICE INTO THE OPPOSITE ARM OF THE PATIENT. THE IFU STATES ON PAGE 3, ¿INTENDED FOR SINGLE PATIENT USE. DO NOT REUSE. BARD ACCESS SYSTEMS, INC. PRODUCTS ARE SINGLE USE DEVICES AND SHOULD NEVER BE REIMPLANTED. REUSE CARRIES WITH IT THE ATTENDANT CONCERN OF CROSS-INFECTION REGARDLESS OF THE CLEANING OR STERILIZATION METHOD.¿ THE GROSHONG CATHETER SHOULD NOT BE REINSERTED INTO A PATIENT AFTER IT HAS ALREADY BEEN USED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "AFTER THE CATHETER INSERTION WAS COMPLETED, AN EVENT OCCURRED IN WHICH THE PATIENT WAS ABLE TO PUSH THE HEPA BLOOD, BUT WAS UNABLE TO OBTAIN A REVERSE BLOOD DRAW. SINCE IT WAS NOT POSSIBLE TO OBTAIN A REVERSE BLOOD DRAW, THE CATHETER WAS REMOVED AND REINSERTED FROM THE OPPOSITE ARM. WHEN CHECKED THE HEPA BLOOD BEFORE INSERTION, IT SEEMED THAT BOTH INJECTION AND ASPIRATION WERE POSSIBLE, HOWEVER, WHEN TRIED TO TEST IT AFTER REMOVAL, IT STILL SEEMED TO BE ABLE TO INJECT BUT NOT ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "AFTER THE CATHETER INSERTION WAS COMPLETED, AN EVENT OCCURRED IN WHICH THE PATIENT WAS ABLE TO PUSH THE HEPA BLOOD, BUT WAS UNABLE TO OBTAIN A REVERSE BLOOD DRAW. SINCE IT WAS NOT POSSIBLE TO OBTAIN A REVERSE BLOOD DRAW, THE CATHETER WAS REMOVED AND REINSERTED FROM THE OPPOSITE ARM. WHEN CHECKED THE HEPA BLOOD BEFORE INSERTION, IT SEEMED THAT BOTH INJECTION AND ASPIRATION WERE POSSIBLE, HOWEVER, WHEN TRIED TO TEST IT AFTER REMOVAL, IT STILL SEEMED TO BE ABLE TO INJECT BUT NOT ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793750 GROSHONG NXT CLEARVUE 4F SL BASIC TRAY W/SAFETY INTRODUCER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHS4188 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other