BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM V SOL 150X15 CON

    MDR report key: 3962834 · Received June 13, 2014

    Report

    Report Number
    9615050-2014-04023
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PARTICULATE THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. THE CUSTOMER CONTACT REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, A HAIR WAS NOTED IN THE SOLUSET OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. 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
    351278 PLM V SOL 150X15 CON 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA