BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2853270 · Received November 21, 2012

    Report

    Report Number
    2853270
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S 1ST UNIT OF PRCS (PACKED RED CELLS) WAS FINISHED INFUSING. THE NURSE WAS UNABLE TO DISCONNECT THE IV TUBING FROM THE J LOOP TO ATTACH THE NEW TUBING FOR THE SECOND UNIT OF PRCS. THERE WAS NOT A REFLUX VALVE ON THE END OF THE J LOOP. THE NURSE TRIED FLUSHING THE LINE WITH SALINE, GRASPING THE TUBING WITH KELLY CLAMPS FOR MORE STABILITY. NO INTERVENTIONS WERE SUCCESSFUL. AN ENTIRE NEW J LOOP WAS OBTAINED AND ATTACHED TO THE IV CATHETER HUB. THE IV ACCESS WAS SUCCESSFULLY MAINTAINED THROUGH THIS PROCESS. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, FLUID DELIVERY FRN HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR