BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 3874393 · Received April 22, 2014

    Report

    Report Number
    9615050-2014-02892
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 24, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K113683
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON 03/31/2014. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED PARTICULATE. THE CUSTOMER CONTACT REPORTED THAT AFTER THE TUBING SET WAS REMOVED FROM THE PACKAGING, PARTICULATE WAS NOTED IN THE TUBING NEAR THE CLAVE Y-SITE OR THE OPTION-LOK MALE ADAPTER. THE CUSTOMER CONTACT REPORTED THE WHITE PARTICULATE LOOKED LIKE EITHER SCRATCH MARKS OR PARTICULATE WITHIN THE WALL OF THE TUBING. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243606 NDHP 0.2 MICRN HP CL 80FPA FPA HOSPIRA LTD. NA 341234W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA