BEUDAMED
    FDA Adverse Event Other Summary report: N

    103S-PLK X BULK SP

    MDR report key: 1406874 · Received June 17, 2009

    Report

    Report Number
    1017768-2009-00119
    Event Type
    Other
    Date Received
    June 17, 2009
    Date of Event
    May 21, 2009
    Report Date
    June 5, 2009
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    COVIDIEN'S CUSTOMER, B. BRAUN, REPORTED TO COVIDIEN THAT A COVIDIEN SYRINGE WAS USED TO ADMINISTER FENTANYL AND DURAMORPH TO A PT FOR LABOR AND DELIVERY PAIN RELIEF ON (B) (6) 2009. THE PT HAD A NORMAL DELIVERY. ON (B) (6) 2009, PT DEVELOPED SEVERE NAUSEA, VOMITING, AND SEIZING. PT WAS PLACED ON A VENTILATOR AND WAS TRANSFERRED TO ANOTHER ACUTE CARE HOSPITAL. THE PT EXPIRED. CUSTOMER REPORTS THIS PT WAS ON NO OTHER CONCOMITANT MEDICATIONS. CUSTOMER STATED THAT THE PT'S BLOOD TESTS REVEALED STREPTOCOCCUS SALIVARIUS. THE SOURCE OF THE STREPTOCOCCUS SALIVARIUS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 103S-PLK X BULK SP BULK PACK SYRINGE FMI COVIDIEN 8881103124 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death