BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2099803 · Received May 23, 2011

    Report

    Report Number
    2090040-2011-00006
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 28, 2011
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASCENT RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. AT THE TIME OF THIS REPORT THE DEVICE HAS NOT BEEN RETURNED TO ASCENT FOR EVALUATION SO AN INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLIANT DEVICE WAS RESTERILIZED THROUGH STRYKER SUSTAINABILITY SOLUTIONS' OPEN-BUT-UNUSED PROCESS. THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR AN EVALUATION SO A ROOT CAUSE COULD NOT BE DETERMINED. THE ORIGINAL MANUFACTURER'S INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO STATE, "STORE UNDER GENERAL WAREHOUSE CONDITIONS. AVOID EXCESSIVE HEAT. PROTECT FROM LIGHT, MOISTURE AND FREEZING CONDITIONS." THEREFORE IT IS POSSIBLE THAT EXPOSURE TO ADVERSE ENVIRONMENTAL CONDITIONS CAUSED THE CATHETER TO BREAK. THIS IS THE FIRST COMPLAINT STRYKER SUSTAINABILITY SOLUTIONS HAS RECEIVED FOR THIS TYPE OF EVENT SO NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE INFUSION CATHETER PART OF THE ON-Q PAIN BUSTER KIT BROKE APART IN SMALL PIECES INSIDE THE PATIENT. TWEEZERS WERE USED TO REMOVE SOME OF THE PIECES BUT NOT ALL OF THE PIECES WERE REMOVED. MEDICINE WAS PLACED BETWEEN THE MUSCLE AND SKIN LAYER AS A PRECAUTION. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A MEB MEB PM025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention