BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET 30IN

    MDR report key: 1467893 · Received June 3, 2009

    Report

    Report Number
    9610175-2009-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2009
    Date of Event
    January 1, 2009
    Report Date
    May 13, 2009
    Manufacturer
    HOSPIRA INC.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 01835. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF AND HAS A 510K OF K941214. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED PAIN MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE FEMALE ADAPTER. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED, "DISTESS TO PT, NO LASTING INJURY AS BREAKAGE WAS SPOTTED EARLY ENOUGH." NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET 30IN UNK FPA HOSPIRA INC. NA 20479VM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK