BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL GROSHONG NXT CLEAR VUE BASIC KIT

    MDR report key: 3964693 · Received May 30, 2014

    Report

    Report Number
    3006260740-2014-00273
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    November 14, 2013
    Report Date
    May 7, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REXG2028 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT (S) FROM THIS LOT NUMBER. THIS COMPLAINT OF AN EXTERNAL CATHETER BREAK IS CONFIRMED. THE CATHETER HAS BEEN RECEIVED IN TWO SECTIONS. THE PROXIMAL SECTION CONTAINS THE ASSEMBLED TWO PIECE CONNECTOR. A SHORT SECTION OF CATHETER TUBING IS SEEN PROTRUDING THROUGH THE DISTAL END OF THE STRAIN RELIEF OVERSLEEVE. THE DISTAL SECTION CONTAINS THE THREE WAY VALVE AND MANUFACTURED TUNGSTEN PLUG. THE BREAK IN THE TUBING IS LOCATED BETWEEN THE 45 AND 46 CM DEPTH MARKERS. THE FEATURES EXHIBITED AT THE BREAK SITE ARE CONSISTENT WITH A BREAK IN THE TUBING AAS OPPOSED TO SHARP INSTRUMENT DAMAGE. THE MECHANISM OF THE BREAK IN THE CATHETER IS UNDERMINED. ACCORDING TO THE NOTES IN THIS FILE THE COMPLAINANT INDICATES THE "NURSE WENT TO FLUSH THIS CATHETER AND THE END PORTION FELL INTO HER HAND." CAUSES FOR THIS TYPE OF DAMAGE RANGE FROM EXCESSIVE TUGGING OR PULLING OF THE CATHETER DURING USE, IMPROPER SECUREMENT OF THE EXTERNAL PORTION OF THE CATHETER, EXCESSIVE TUGGING/PULLING FROM THE PT, ACCIDENTAL SNAGGING DURING PT ACTIVITY, BREAKAGE DURING TUNNELING, AND BREAKAGE DURING REMOVAL. DUE TO THE DELICATE NATURE OF SILICONE TUBING, THE USER IS CAUTIONED TO ALWAYS USE CARE WHEN HANDLING THE CATHETER. THE PRODUCT INSTRUCTIONS FOR USE (IFU) CAUTION THE USER TO MINIMIZE THE RISK OF CATHETER BREAKAGE AND EMBOLIZATION BY SECURING THE CATHETER IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC PLACED ON (B)(6) 2013. NURSE WENT TO FLUSH THIS CATHETER AND THE END PORTION FELL INTO HER HAND. DIFFICULT TO KNOW WHETHER ANY EVENT SUCH AS STRETCHING WHICH COULD HAVE LED TO A COMPLETE BREAK OF THE CATHETER INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320053 4 FR SL GROSHONG NXT CLEAR VUE BASIC KIT LJS BARD ACCESS SYSTEMS REXG2028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention