BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE PUMP PACK

    MDR report key: 2163792 · Received July 2, 2011

    Report

    Report Number
    2163792
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 2, 2011
    Manufacturer
    SRI SURGICAL
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMALL SUTURE NEEDLE (NEEDLE ONLY) DISCOVERED UPON OPENING STERILE DISPOSABLE PUMP PACK. THE SUTURE NEEDLE WAS FOUND INSIDE THE WHITE CUP LID INSIDE THE PACK. THERE IS NO SUTURE FOUND IN THE PACK, NO REASON FOR THE NEEDLE TO BE THERE. THESE PACKS ARE USED FOR OPEN HEART, PUMP CASES. THE NEEDLE WAS REMOVED AND TAKEN TO PURCHASING ALONG WITH THE IDENTIFING INFORMATION, AND THE COMPANY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE PUMP PACK STERILE PUMP PACK FSM SRI SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR