BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD ENTERAL ACCESS DILATION SYSTEM

    MDR report key: 8944778 · Received August 29, 2019

    Report

    Report Number
    8944778
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 24, 2019
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KGC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN IR (INTERVENTIONAL RADIOLOGY) FOR A GJ PEG TUBE PLACEMENT. DURING PLACEMENT, MD DID NOT ENCOUNTER ANY UNUSUAL CIRCUMSTANCES OTHER THAN A SLIGHT "CATCH" OF THE DILATOR AS PEEL AWAY SHEATH WAS SEPARATING FROM THE DEVICE. POST PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. CT SCAN OF THE ABDOMEN REVEALED BOWEL PERFORATION AND RETAINED FOREIGN OBJECT. PATIENT WAS SENT TO OR AND FOREIGN OBJECT WAS REMOVED AND DISCOVERED TO BE A PART OF THE DEVICE THAT WAS NOT SUPPOSED TO SEPARATE FROM PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739684 HALYARD ENTERAL ACCESS DILATION SYSTEM TUBE, GASTRO-ENTEROSTOMY KGC AVANOS MEDICAL, INC. 98703-01

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA