BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD MICROBORE SET

    MDR report key: 1083358 · Received July 28, 2008

    Report

    Report Number
    9613251-2008-00284
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 3, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K991932
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED THREE POSSIBLE LOT NUMBERS. THE POSSIBLE LOT NUMBERS ARE 64133NS, 60103NS, AND 63146NS. DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A RADIOISOTOPE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED RADIOISOTOPE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT NOTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE CLAVE PORT. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WERE NO REPORTED EXPOSURE OR ADVERSE EFFECTS TO THE PT OR THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD MICROBORE SET 80FPK FPK HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK