BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM PREPIERCED Y

    MDR report key: 1776038 · Received July 22, 2010

    Report

    Report Number
    9615050-2010-00135
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 24, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID INTO THE SOLUTION CONTAINER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF PARENTERAL NUTRITION AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED THAT, "DURING PARENTAL NUTRITION USER NOTICED BACKFLOW OF THE LIQUID IN THE POUCH." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE INCLUDING, IF THE TUBING SET WAS BEING USED WITH A PUMP, DESCRIPTION OF THE TUBING SET UP, AND CLARIFICATION OF THE EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM PREPIERCED Y UNK FPA HOSPIRA COSTA RICA LTD. NA 761585H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK