BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK SYRINGES

    MDR report key: 3010939 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00004
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED. THIS MEDWATCH IS 2 OF 5 RELATED INCIDENTS THAT OCCURRED: 2243072-2013-00003, 2243072-2013-00005, 2243072-2013-00006, 2243072-2013-00007.

    Description of Event or Problem · 1

    PATIENT ANESTHETIZED USING TCI PROPOFOL. A FEW MINUTES AFTER ENTERING THEATRE TCI PUMP ALARMED OCCLUSION. ALL LINES WERE CHECKED FOR OCCLUSION BUT WERE ALL FREE. THE PATIENT MOVED DURING THIS FRAME OF TIME INDICATING SHE MIGHT NOT HAVE BEEN RECEIVING PROPOFOL FROM THE PUMP DURING THIS TIME. ON CHECKING THE BD 50ML SYRINGE LOT 1208225 - THE PLUNGER WAS REALLY HARD TO INJECT AND ALMOST SOLID. A SECOND SYRINGE WAS PREPARED AND USED UNEVENTFULLY FOR REST OF THE CASE AND THE PATIENT WAS DEEPENED USING A PROPOFOL BOLUS FROM ANOTHER SYRINGE TOGETHER WITH A VOLATILE ANAESTHETIC DURING THE EVENT. PUMP CHECKED OUT ON THE (B)(6) 2013 AS NOT FAULTY. COMPANY FOR THE SYRINGE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110453 BD PLASTIPAK SYRINGES HYPODERMIC SYRINGE FMF BECTON DICKINSON 1208225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention