BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEPICO ASPIRATOR

    MDR report key: 2161947 · Received May 13, 2011

    Report

    Report Number
    3002807968-2011-00009
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JKA
    PMA / PMN Number
    K043143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEETING WAS HELD WITH THE ICU NURSES, NURSE MANAGERS, TRAINERS AND A REP FROM CENTRAL SERVICES. THE NURSES' PROCEDURE WAS OBSERVED AND PROPER USE OF THE DEVICE WAS DEMONSTRATED. FROM THE MEETING, IT WAS CLEAR THAT THE PRODUCT WAS FUNCTIONING PROPERLY. THE LOCAL RADIOMETER REPRESENTATIVE WILL PROVIDE ADDITIONAL USER TRAINING, TRAINING MATERIAL AND FOLLOW-UP SUPPORT. A FOLLOW UP REPORT WILL BE FILED WHEN INFORMATION ABOUT THE NURSE'S CONDITION IS AVAILABLE.

    Description of Event or Problem · 1

    A NURSE IN THE ICU HAD DIFFICULTY PUSHING THE SAFETY SHIELD IN PLACE TO COVER THE NEEDLE OF A SAFEPICO ASPIRATOR. SHE PASSED THE SAMPLER OVER TO AN ASSISTING NURSE, WHO THEN STUCK HERSELF ON THE NEEDLE WHEN TRYING TO CLOSE THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFEPICO ASPIRATOR ARTERIAL BLOOD SAMPLER JKA RADIOMETER MEDICAL APS SAFEPICO 22G X 32MM DI-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Other