BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2384278 · Received December 21, 2011

    Report

    Report Number
    2090040-2011-00038
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Product Code
    OEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE DEVICES WERE RETURNED TO SSS IN THEIR ORIGINAL PACKAGING. UPON INSPECTION, THE POUCHES WERE FOUND TO BE UNSEALED AT THE SEAL OPPOSITE OF THE CHEVRON SEAL. IT WAS EVIDENT THE POUCHES HAD NO SEAL MARKS TO INDICATE THEY HAD BEEN SEALED AT SOME POINT. THE MOST LIKELY CAUSE FOR THE DEVICES NOT BEING SEALED IS LIKELY DUE TO AN OVERSIGHT BY IN-HOUSE OPERATORS. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO INCLUDE ADDITIONAL INSTRUCTIONS FOR SEAL INSPECTION. PERSONNEL RESPONSIBLE FOR OPEN-BUT-UNUSED PACKAGING WILL BE RETRAINED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SHEATH INTRODUCER PACKAGES WERE NOT SEALED WHEN THEY WERE BEING PULLED FOR A PROCEDURE AT THE USER FACILITY. THE DEVICES WERE NEVER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A OEX OEX 401-790M

    Patients

    Seq Age Sex Outcome Treatment
    1