BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC

    MDR report key: 2479492 · Received February 27, 2012

    Report

    Report Number
    2479492
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 27, 2012
    Manufacturer
    BARD ACCESS SYSTEMS, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    FATHER PICKED TUBING UP TO HELP PATIENT TO THE BATHROOM AND PORT TUBING HAD SNAPPED (BLUE TIP, ABOVE THE WINGS OF THE CATHETER). PORT HAD TO BE DE-ACCESSED AND RE-ACCESSED. IV FLUIDS WERE CONTAMINATED DUE TO THE BREAK AND NEW ONES OBTAINED FROM PHARMACY. MINOR DELAY IN RESTARTING INFUSION. NO NEGATIVE OUTCOME FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC INTRAVASCULAR TUBING FPA BARD ACCESS SYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR