BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 2894700 · Received December 26, 2012

    Report

    Report Number
    2894700
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 14, 2012
    Report Date
    December 26, 2012
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    HRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD AN OPEN CHEST. THEY HAD PERFORMED MULTIPLE BEDSIDE STERNOTOMIES IN AN EFFORT STABILIZE BLEEDING. THE CHEST HAD BEEN LEFT OPEN WITH STERILE PACKING IN PLACE. THE HEMOSTATS WERE ATTACHED TO THE STERILE PACKING. WHEN THE MD WENT TO REMOVE THE HEMOSTAT, HE NOTED THAT THE CLAMP WAS BROKEN. AS THEY REMOVED THE DRESSING THE BROKEN PIECE WAS READILY FOUND LYING AMONGST THE REMAINING DRESSINGS. DISCUSSION WITH CRITICAL CARE NURSE NOTES THAT THIS WAS NOT THE FIRST TIME THE HEMOSTAT CLAMP HAD BROKEN, BUT SHE HAD NOT THOUGHT TO MAKE A REPORT OF PREVIOUS INCIDENTS AS THEY WERE "MINOR" OCCURRENCES AND NOT IN DIRECT CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE INSTRUMENT, SURGICAL, HEMOSTAT HRQ OWENS & MINOR DISTRIBUTION, INC. KELLY HEMOSTAT, STRAIGHT, 5.5" *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR