BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE MULTIPAK (2-60ML SYRINGES

    MDR report key: 2063254 · Received March 22, 2011

    Report

    Report Number
    9610849-2011-00006
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COVIDIEN (B)(4) CUSTOMER REPORTS FOREIGN OBJECT FOUND INSIDE THE SYRINGE. LOOKS LIKE A PIECE OF A PLASTIC TIP. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR LE MULTIPAK (2-60ML SYRINGES EMPTY, DISPOSABLE SYRINGE DXT COVIDIEN EMPTY 60ML SYRINGE 0232153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA