BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 2091304 · Received April 20, 2011

    Report

    Report Number
    3002859087-2011-00017
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    January 1, 2008
    Report Date
    April 18, 2011
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008 FOR FEMORAL POSTERIOR TIBIAL COMPOSITE GRAFT. WHILE HOSPITALIZED, THE PATIENT WAS ADMINISTERED HEPARIN AND BEGAN TO HAVE SYMPTOMS CONSISTENT WITH THE HYPERSENSITIVITY-TYPE ADVERSE REACTIONS FROM CONTAMINATED HEPARIN. UPON INFORMATION AND BELIEF, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO THE PATIENT WAS ALLEGED TO BE CONTAMINATED HEPARIN. SHORTLY THEREAFTER, THE PATIENT BEGAN TO EXPERIENCE ADVERSE REACTIONS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PREFILL HEPARIN PREFILL NZW COVIDIEN UNKNOWN PREFILL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN