BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 4535382 · Received February 12, 2015

    Report

    Report Number
    3006260740-2015-00064
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Report Date
    October 7, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED AND THE CAUSE IS USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 4 FR GROSHONG NXT SINGLE LUMEN CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE CATHETER SPLIT WAS LOCATED BETWEEN THE 35 AND 36 CM DEPTH MARKERS, AND THE OBSERVED DAMAGE WHICH IS CHARACTERISTIC OF THIS FAILURE TYPE INCLUDED: CIRCUMFERENTIALLY ALIGNED SPLIT IN THE CATHETER, ROUNDED FRACTURE EDGES, AND POLISHED FEATURES DUE TO MATERIAL WEAR. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT.

    Description of Event or Problem · 1

    PICC PLACED (B)(6) 2014. LEAK IN PICC (B)(6) 21014. 3 LEAKS FOUND IN THIS PICC LOCATION UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103463 PERIPHERALLY INSERTED CENTRAL CATHETER UNK LJS BARD ACCESS SYSTEMS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention