BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 2961209 · Received February 8, 2013

    Report

    Report Number
    3006260740-2013-00060
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 21, 2013
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNCONFIRMED. RETURNED FOR EVALUATION IS A GROSHONG 4 FR PICC CATHETER. THE COMPLAINT SAMPLE WAS RETURNED IN TWO SECTIONS. BOTH SECTIONS FUNCTIONED NORMALLY DURING FUNCTIONAL TESTING. BOTH SECTIONS OF THE COMPLAINT SAMPLE REVEALED NO LEAKS DURING HYDRAULIC PRESSURIZATION. GROSS VISUAL, FUNCTIONAL AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINT INCIDENT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. A LOT HISTORY REVIEW (LHR) OF REWD1009 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS PLACED A PICC LINE FOR CHEMOTHERAPY FOR ONE AND HALF MONTHS, ON (B)(6) 2013, WHEN THE NURSE DID REGULAR MAINTENANCE, SHE FOUND THERE WAS A LEAK IN THE CATHETER, SO AFTER CAREFULLY EVALUATION, SHE PULLED OUT OF THE CATHETER AND CHANGED ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53875 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD, INC. (BASD) REWD1009

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention