BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET 0.2 FLTR CLV YSITE 104IN NDEHP

    MDR report key: 3172398 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01518
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED SEPARATION WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE TUBING SET WAS PRIMED, IT WAS REPORTED THAT THE TUBING SEPARATED FROM AN UNSPECIFIED LOCATION OF THE PRE-PIERCED Y-SITE OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249561 PLUMSET 0.2 FLTR CLV YSITE 104IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA