BEUDAMED
    FDA Adverse Event Other Summary report: N

    60CC SYRINGE ONLY LUER LOCK TIP

    MDR report key: 2132174 · Received June 4, 2011

    Report

    Report Number
    1650158-2011-00003
    Event Type
    Other
    Date Received
    June 4, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 24, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2011 THAT A CUSTOMER HAD AN ISSUE WITH EXPELLING MEDICATION FROM A MONOJECT SYRINGE. THE CUSTOMER ALLEGES THAT ON (B)(6) 2011 DURING A PROCEDURE, THE MONOJECT 60 ML SYRINGE FILLED WITH LEVOPHED TO MAINTAIN THE BLOOD PRESSURE ON THE PT FAILED TO EXPEL THE MEDICATION. THE CUSTOMER REPORTS, IT WAS INITIALLY PUT INTO A BAXTER PUMP AS50, BUT THE MEDICATION WOULD NOT EXPEL AND THE SYRINGE WAS THEN REMOVED FROM THE PUMP. THE CLINICIANS ATTEMPTED TO MANUALLY BOLUS THE MEDICATION BUT STILL NO MEDICATION WAS DISPENSED. THE CUSTOMER REPORTED FILLING A 2ND 60 ML SYRINGE AND RETRYING THE PUMP APPLICATION AND MANUAL COMPRESSION OF THE DRUG AND THIS SYRINGE ALSO FAILED. THE CUSTOMER STATED THEY WERE UNABLE TO PROCEED AS NORMAL SINCE THE PT HAD NO SIGNS OF A BLOOD PRESSURE FOR APPROX 10 - 15 MINUTES. THE CUSTOMER APPLIED OTHER PROCEDURES TO STABILIZE THE PT AND THE PT WAS SENT TO ICU FOR RECOVERY. NO ADD'L INFO WAS PROVIDED REGARDING THE PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60CC SYRINGE ONLY LUER LOCK TIP SYRINGE FMF COVIDIEN 1186000777 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention