BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.C. 5000/CE NITROGL

    MDR report key: 1483517 · Received July 27, 2009

    Report

    Report Number
    9615050-2009-00164
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 2, 2009
    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
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11878. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K810317. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE AIR FILTER VENT ON THE PIERCING PIN. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L.C. 5000/CE NITROGL UNK FPA HOSPIRA COSTA RICA LTD. NA 702075H

    Patients

    Seq Age Sex Outcome Treatment
    1