BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA PRIMARY TUBING

    MDR report key: 2770194 · Received September 21, 2012

    Report

    Report Number
    2770194
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 21, 2012
    Manufacturer
    HOSPIRA,INC.
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HOSPIRA PRIMARY TUBING BROKE AT END WHILE ATTACHED TO THE J LOOP. PATIENT NOTICED THAT SOMETHING WAS LEAKING. BROKE WHERE THE TUBING SCREWS INTO THE J LOOP ON IV CAUSING IV FLUID TO LEAK.ADDITIONAL DEVICE INFORMATION WILL BE FORWARDED IF AVAILABLE. WE HAVE SEEN THIS KIND OF PROBLEM WITH THIS DEVICE BEFORE.THERE ARE ISSUES AT 3 DIFFERENT POINTS OF CONNECTION REPORTED REGARDING THE TUBING:1. WHEN THE PRIMARY IV TUBING IS CONNECTED TO THE J-LOOP. WE HAVE 2 J-LOOP/EXTENSION SETS IN USE; IT IS UNKNOWN WHICH WAS BEING UTILIZED IN THE REPORTED INCIDENT.2. WHEN PRIMARY IV TUBING IS CONNECTED TO THE BLUE PORT (CLAVE) OF ANOTHER PRIMARY SET.3. AT THE POINT OF CONNECTION OF THE SECONDARY TUBING AND BLUE PORT (CLAVE) OF PRIMARY TUBING ABOVE THE LEVEL OF THE IV PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA PRIMARY TUBING TUBING, FLUID DELIVERY FPK HOSPIRA,INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR