BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005053560-2018-00001

    MDR report key: 7724866 · Received July 26, 2018

    Report

    Report Number
    3005053560-2018-00001
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 24, 2018
    PMA / PMN Number
    K050301
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS REPRESENTATIVE INFUSION SETS FORM THIS SAME LOT, AND HAS SENT SAMPLES FOR IRADIMED'S EXAMINATION. THESE SAMPLES ARE IN TRANSIT FROM THE HOSPITAL. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE PRODUCT SAMPLES HAVE ARRIVED, AND HAVE BEEN EXAMINED BY IRADIMED CORPORATION.

    Description of Event or Problem · 1

    REPORTER ((B)(6)) STATED THAT DURING SETUP OF THE INFUSION ADMINISTRATION LINE, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DISPOSABLE PLASTIC END-CAP OF THE INFUSION SET. THE PHYSICIAN COULD NOT TWIST OFF THE END-CAP, AND SUBSEQUENTLY INJURED HIMSELF WHILE ATTEMPTING TO REMOVE THE SOFT POLYETHYLENE CAP FROM THE PLASTIC LUER-LOCK END OF THE INFUSION SET. THE REPORTER STATED THE PLASTIC LUER-LOCK END OF THE INFUSION SET PENETRATED THE PHYSICIAN'S GLOVE AND BROKE THE SKIN. NO TOOLS OR OTHER IMPLEMENTS WERE USED AT THIS TIME. THE SUSPECT INFUSION SET WAS DISCARDED FOLLOWING THE EVENT. NO SERIOUS ADVERSE EVENT OCCURRED, AND DID NOT INVOLVE ANY PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1