BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK PREFILL

    MDR report key: 1422214 · Received March 19, 2009

    Report

    Report Number
    3002859087-2009-00011
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    January 1, 2007
    Report Date
    March 17, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 03/17/2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PT HAS BEEN ON TPN SINCE APPROX (B) (6) 2006 TO THE PRESENT. AS PART OF THE ADMINISTRATION OF TPN IT IS REQUIRED TO FLUSH HER PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) LINE WITH HEPARIN. ON (B) (6) 2007, PT BEGAN GETTING SERIOUSLY ILL WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO VOMITING, SEVERE ABDOMINAL PAINS, NAUSEA, AND SOB. SYMPTOMS WERE SO SEVERE THAT SHE REQUIRED HOSPITALIZATION ON NUMEROUS OCCASIONS. ON (B) (6) 2007, PT WAS ADMITTED TO THE HOSPITAL WITH VOMITING AND SEVERE ABDOMINAL PAIN. ON (B) (6) 2007 PT ADMITTED TO HOSPITAL WITH C/O SOB AND SEVERE N/V WHILE IN THE HOSPITAL SHE ALSO SUFFERED FROM A SEIZURE. ON (B) (6) 2007, PT ADMITTED WITH C/O SEVERE ABDOMINAL PAIN AND N/V. ON (B) (6) 2008, PT ADMITTED WITH C/O SEVERE ABDOMINAL PAIN, N/V, AND SUFFERED ANOTHER SEIZURE. DUE TO THIS SECOND SEIZURE SHE WAS PRESCRIBED ANTI-SEIZURE MEDICATIONS WHICH SHE CONTINUES TO TAKE TODAY. ON (B) (6) 2008, AGAIN ADMITTED TO THE HOSPITAL WITH C/O WEAKNESS, DIZZINESS, AND ABDOMINAL PAIN. DURING THIS HOSPITALIZATION SHE EXPERIENCED HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PREFILL HEPARIN PREFILL SYRINGE NZW COVIDIEN UNK PREFILL 7072154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization