BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXT SET

    MDR report key: 1348788 · Received February 5, 2009

    Report

    Report Number
    9613251-2009-00017
    Event Type
    Malfunction
    Date Received
    February 5, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 22, 2009
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 WAS INVOLVED IN THE REPORTED EVENT WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11572. THE DOMESTIC LIST NUMBER 11572 HAS A 80FPK COMMON DEVICE AND HAS A K063239 510K. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY BLEED BACK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, A LEAK OF SOLUTION WAS NOTED FROM AN UNSPECIFIED LOCATION AND BLEED BACK WAS NOTED IN THE TUBING. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROBORE EXT SET UNK FPA HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK