BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER

    MDR report key: 6847208 · Received September 6, 2017

    Report

    Report Number
    3006260740-2017-01548
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 11, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741086991
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REZJ1983 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. DEVICE NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT THE CHILD PATIENT UNDERWENT PICC PLACEMENT IN (B)(6) 2016. AFTER FINDING THAT BLOOD COULD NOT BE DRAWN RECENTLY, THE PROBLEM WAS RESOLVED BY ADOPTING UROKINASE THROMBOLYTIC THERAPY AT THE DEPARTMENT. LATER, DURING CATHETER MAINTENANCE ON (B)(6) 2017, IT WAS FOUND THAT ADHESION SEEMED TO OCCUR ON THE CATHETER. IT WAS THEN FOUND THAT SERIOUS VASCULAR ADHESION OCCURRED UNDER ULTRSOUND. THE INTERVENTION DEPARTMENT WAS INVITED TO ASSIST IN PULLING OUT THE CATHETER, WHICH WAS ONLY PULLED OUT FOR 6CM, WITH 24CM OF BROKEN PART LEFT IN VIVO SINCE THE TOTAL LENGTH OF PLACEMENT WAS 30CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624548 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS N/A REZJ1983 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention