BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS

    MDR report key: 1816255 · Received August 20, 2010

    Report

    Report Number
    MW5017226
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 20, 2010
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, A HUBER NEEDLE BROKE OFF IN A PATIENT'S CHEST. THE HUBER NEEDLE WAS PLACED IN PATIENT'S CHEST AT (B)(6) CLINIC AT (B)(6) MEDICAL CENTER -(B)(6) CANCER CENTER. PLACED BY DR (B)(6) CLINIC. DATE OF INSERTION (B)(6) 2010 AT 9:10 AM. GRIPPER PLUS NON CORING SAFETY NEEDLE MANUFACTURER SMITHS MEDICAL MD INC. LOT/BATCH 202X30 REF/CATALOG 21-2966-24. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS NON CORING SAFETY NEEDLE FMI SMITHS MEDICAL MD, INC. 202X30

    Patients

    Seq Age Sex Outcome Treatment
    1