BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP MACRO PPR T CON

    MDR report key: 3172410 · Received June 5, 2013

    Report

    Report Number
    9613251-2013-00171
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K113683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 24206NS. 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 TUBING RUPTURE WHILE IN USE WITH A POWER INJECTOR. ON AN UNSPECIFIED DATE, THE MALE ADAPTER OF AN UNSPECIFIED POWER INJECTOR TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF OMNIPAQUE CONTRAST MEDIUM, AT A RATE OF 3.2ML/SEC, VIA A POWER INJECTOR. THE CUSTOMER CONTACT REPORTED THAT FIVE MINUTES AFTER THE DELIVERY WAS STARTED, THE TUBING RUPTURED AT AN UNSPECIFIED LOCATION ON THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT A NEW IV ACCESS SITE WAS STARTED. NO SPECIFIC DETAILS WERE PROVIDED. THE EXTENSION TUBING SET WAS REPLACED AND THE PROCEDURE WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249354 NDHP MACRO PPR T CON 80FPA FPA HOSPIRA LTD. NA PLOTSNS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED POWER INJECTOR, MFG BY MED RAD| OMNIPAQUE CONTRAST MEDIUM, MFG BY GE HEALTHCARE