BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11931546 · Received June 3, 2021

    Report

    Report Number
    3006260740-2021-02135
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    April 17, 2021
    Report Date
    May 11, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741086991
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDR1628 SHOWED 9 OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR POSTOPERATIVE CHEMOTHERAPY FOR COLON CANCER. HE WAS GIVEN THE THIRD INTRAVENOUS CHEMOTHERAPY WITH AI HENG, CF, AND 5FU PUMPS. THE PATIENT WAS GIVEN INTRAVENOUS DRIP AI HENG AT 12:29. AT THAT TIME, THERE WAS NO REDNESS AND SWELLING AT THE PICC PUNCTURE SITE. AT 13:35 MINUTES, THE NURSE WATCHED THE PATIENT'S INFUSION AND THE LIMB WAS SWOLLEN. THE INFUSION WAS STOPPED, BLOOD WAS DRAWN BACK, AND THE PUNCTURE SITE HAD PALE BLOOD LEAKAGE. THE ARM CIRCUMFERENCE OF THE AFFECTED LIMB WAS 29CM AND THE EXUDATION WAS MEASURED. THE AREA IS 15*22CM, THE UNINVOLVED ARM CIRCUMFERENCE IS 27CM, THE SKIN HAS NO REDNESS, AND THE PATIENT COMPLAINS OF SLIGHT SWELLING AND PAIN. THE NRS SCORE IS 1 POINT, AND THE PATIENT SHOULD BE COMFORTED. THE CHEST RADIOGRAPH SHOWED THAT THE 7TH THORACIC VERTEBRA AT THE TIP OF THE PICC CATHETER, AND B-ULTRASOUND SHOWED THAT THE BLOOD VESSELS WERE SMOOTH. WHEN THE STATIC THERAPY SPECIALIST NURSE FLUSHED THE PICC PIPE WITH 20ML OF SALINE, THERE WAS A LIGHT BLOOD SEEPAGE AT THE PUNCTURE SITE. WHEN THE PICC PIPE WAS PULLED OUT ABOUT 3CM, THERE WAS A BREACH, AND THE FLUSHING PIPE HAD LIQUID OUTFLOW. THE PICC TUBE WAS REMOVED, AND THE DOCTOR ORDERED A WARM COMPRESS OF 100ML NORMAL SALINE + 50MG DEXAMETHASONE. NOW THE PATIENT COMPLAINS OF A SLIGHT NUMBNESS AND PAIN IN THE AFFECTED LIMB. THE NRS SCORE IS 1 POINT, AND THE RELEVANT COMFORT WORK IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824827 GROSHONG NXT CV 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 REDR1628 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention