BEUDAMED
    FDA Adverse Event Other Summary report: N

    30327 12CC 100 UNIT HEP SYR (CAN) (5CC)

    MDR report key: 1295849 · Received January 21, 2009

    Report

    Report Number
    3002859087-2009-00003
    Event Type
    Other
    Date Received
    January 21, 2009
    Date of Event
    January 4, 2009
    Report Date
    January 14, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED. IT SHOULD BE NOTED THAT THIS PRODUCT UNDERGOES A TERMINAL STERILIZATION PROCESS, WHICH WOULD EASILY DESTROY THE REPORTED ORGANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 01/14/2009 THAT A CUSTOMER HAD AN ISSUE WITH A PRE-FILLED SYRINGE. CUSTOMER REPORTS SHE BEGAN FEELING ILL ON (B) (6) FOLLOWING FLUSHES TO HER PICC LINE WHICH IS DONE EVERY 12 HOURS. CUSTOMER REPORTS BY (B) (6), SHE SPIKED A TEMPERATURE OF 104.2 AND EXPERIENCED EXTREME BODY ACHES FOLLOWING NIGHT DOSAGE OF TWO 10ML SODIUM CHLORIDE FLUSHES AND ONE 5ML HEPARIN FLUSH. CUSTOMER REPORTS SHE WENT TO THE EMERGENCY ROOM AND WAS ADMITTED AND DIAGNOSED WITH SERRATIA MARCESCENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 100 UNIT HEP SYR (CAN) (5CC) PRE-FILL SYRINGE NZW COVIDIEN 8881590125 8102564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization