BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP MACRO 20IN EXT

    MDR report key: 1931710 · Received November 22, 2010

    Report

    Report Number
    9613251-2010-00156
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED PARTICULATE. THE TUBING SET WAS BEING USED WITH A LUMBAR PUNCTURE KIT TO COLLECT CEREBRAL SPINAL FLUID DURING A LUMBAR PUNCTURE PROCEDURE. IT WAS REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED, "FOREIGN BODIES" WERE NOTED IN TWO VIALS FROM THE UNSPECIFIED LUMBAR PUNCTURE KIT THAT CONTAINED UNSPECIFIED VOLUMES OF CEREBRAL SPINAL FLUID. THE CUSTOMER CONTACT REPORTED THAT TESTING BY THE USER FACILITY'S PATHOLOGY DEPARTMENT IDENTIFIED THE PARTICULATE AS "NON-ORGANIC, POSSIBLY PLASTIC". 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 PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP MACRO 20IN EXT 80FPK FPK HOSPIRA LTD. NA 90193NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED LUMBAR PUNCTURE KIT, MANUFACTURED| BY CAREFUSION.