BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE CATHETER 4F SINGLE LUMEN

    MDR report key: 18182539 · Received November 20, 2023

    Report

    Report Number
    MW5148344
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    September 17, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    UDI-DI
    00801741086991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS DIAGNOSED WITH NEUROBORRELIOSIS LEADING TO MENINGITIS AND WAS ADVISED 2 WEEKS OF IV MONOCEF AND DOXYCYCLINE BD . THE PATIENT OPTED FOR PICC THAT WOULD LAST FOR AROUND 6 MONTHS TO AVOID FREQUENT IV CANULATION CHANGES. THE PATIENT WAS OPERATED ON (B)(6) 2023 AROUND 2 PM BY SENIOR ONCOLOGIST DR. (B)(6) AT (B)(6) ON RIGHT ARM IN BASILIC VEIN. GROSHONG NXT CATHETER WITH REFERENCE (B)(4) 4F SINGLE LUMEN, 60 CM LENGTH WITH LOT REGS2795 WITH EXPIRY DATE 2024/08/31 WAS INSERTED. THE OPERATION WAS SUCCESSFUL AND THE PATIENT WAS ADVISED IN DETAIL ABOUT THE CARE AND MAINTENANCE OF THE DEVICE. INJ HEPLOCK FLUSH SOLUTION WAS USED TO FLUSH THE CATHETER. PATIENT WAS GIVEN IV ANTIBIOTICS TWICE DAILY TILL (B)(6) MORNING. ON THE 16TH EVENING THE WHEN THE IV FLUIDS WERE BEING GIVEN THE DRIP STARTED TO LEAK. THEN IT STOPPED LEAKING AND THE DRIP WAS COMPLETED. ON 17TH MORNING WHEN THE PATIENT ARRIVED HE HAD A STIFF HAND. WHEN THE DRIP WAS STARTED IT DID NOT GO THROUGH BUT THE IV FLUIDS STARTED COMING BACK. AS DR. (B)(6) REMOVED THE BANDAGE FROM THE CENTRAL LINE PORT, ONLY THE BUTTERFLY PART OF THE PORT WAS ATTACHED AND THE BLUE LINE CATHETER WAS NOT THERE. IT WAS VERY PUZZLING FOR EVERYONE. CHECKED X RAY WAS DONE IMMEDIATELY TO KNOW THE POSITION OF THE CATHETER.( TIME 2.30 PM IST) IT HAD MIGRATED UPTO MID UPPER ARM. SURGERY WAS PLANNED IMMEDIATELY AFTER INVESTIGATIONS. PATIENT WAS OPERATED ON (B)(6) 2023 UNDER C ARM GUIDANCE. AS PER LITERATURE, EARLY FRACTURE OF PICC IS UNCOMMON OR RATHER UNKNOWN. ALSO, I WOULD LIKE TO KNOW THE FDA INSPECTION REPORT OF BARD MANUFACTURING CENTER AT PRAQUE INDUSTRIAL COLONIAL REYNOSA, MEXICO AS THERE HAD BEEN RECALL OF BARD MAGIC3 GO, INTERMITTENT URINARY CATHETER IN APRIL 2023. ( RECALL NUMBER Z-16987-2023). I WOULD LIKE TO KNOW WHY CATHETER WAS FRACTURED SO EARLY AS IT IS VERY UNUSUAL. BEFORE REMOVAL OF PICC ON (B)(6) 2023, RELEVANT INVESTIGATIONS LIKE CBC(COMPLETE BLOOD COUNT), LFT(LIVER FUNCTION TEST), KFT, HIV, HBS(HEMOGLOBIN) AG(ALBUMIN/GLOBULIN) TESTING ALONG WITH X RAYS OF THE RT ARM WERE DONE. PICC REMOVAL WAS DONE C -ARM GUIDANCE. PT IS HAVING CHRONIC NEUROBORRELIOSIS WITH MENINGITIS FOR WHICH HE HAD BEEN PRESCRIBED IV ANTIBIOTICS BY INFECTIOUS DISEASE SPECIALIST. IG E IS AROUND 1100 HE IS ALSO HAVING MITRAL VALVE PROLAPSE SINCE 2017. PICTURES ARE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264912 GROSHONG NXT CLEARVUE CATHETER 4F SINGLE LUMEN CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. REGS2795 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Hospitalization| R| L