BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE YSITE 104IN NDEHP

    MDR report key: 3832345 · Received February 10, 2014

    Report

    Report Number
    9615050-2014-01044
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 A SEPARATION. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT A RATE OF 75ML/HR, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE TUBING SEPARATED FROM THE ARM OF THE INTEGRAL CLAVE Y-SITE OF THE TUBING SET. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87942 PLUMSET CLAVE YSITE 104IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK