BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HASKAL TRANSJUGULAR INTRAHEPATIC PORTAL ACCESS SET

    MDR report key: 2132207 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00300
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    COOK, INC.
    Product Code
    GBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF DEVICE PORTION IS NOT LABELED IN THE IFU. DEVICE SEPARATION IS NOT LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN FINISHED THE TIPS PROCEDURE AND SENT THE PT TO POST-OP. THEY CALLED TO LET THE TECHNICIANS KNOW THAT THERE WAS MATERIAL STUCK IN HER NECK. THE PHYSICIAN THINKS THAT MAYBE SOME OF THE NEEDLE SHEARED OFF THE MATERIAL. IT WAS A TOUGH CASE WHERE THEY WERE IN AND OUT OF THE SHEATH MULTIPLE TIMES. HE DOES NOT THINK ANYTHING WAS WRONG WITH OUR SET. TECHNICIAN PULLED THE PORTION OUT OF THE PT'S NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HASKAL TRANSJUGULAR INTRAHEPATIC PORTAL ACCESS SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK, INC. NA 2686025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention