BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 3162974 · Received March 18, 2013

    Report

    Report Number
    3162974
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 3, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BARD MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RUPTURED DUAL LUMEN HICKMAN CATHETER. TOTAL OF THREE, SEPARATE DUAL LUMEN HICKMAN RUPTURES, REQUIRING SURGICAL REPLACEMENT. ALL PRE-FILLED SALINE SYRINGES ARE VERIFIED TO BE 10-ML IN SIZE SO ALL FLUSHES HAVE BEEN DONE CORRECTLY. BARD REPRESENTATIVES ON-SITE (B)(6) 2013. PICTURES OF PREVIOUSLY RUPTURED, 2 CATHETERS SENT TO BARD ON (B)(6) 2013. BARD ENGINEER ARE CURRENTLY REVIEWING INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112426 BARD DUAL LUMEN HICKMAN CATHETER LJS BARD MEDICAL HUWE1380

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention