BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WNTHRP CPJT HOLDERS 2ML/5ML (F)

    MDR report key: 3410581 · Received September 20, 2013

    Report

    Report Number
    1925262-2013-00001
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 23, 2013
    Manufacturer
    HOSPIRA, INC.
    Product Code
    IQG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED DEVICE BREAKAGE 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE PT REPORTED DEVICE BREAKAGE. THE PT REPORTED THAT THE CARPUJECT HOLDER WAS BEING USED TO DELIVER HEPARIN SODIUM 5,000U/0.5 ML EVERY 8 HOURS, VIA SELF-ADMINISTERED SUBCUTANEOUS INJECTIONS. ON (B)(6) 2013 AT 0800, IT WAS REPORTED THAT WHILE A PREFILLED MEDICATION CARTRIDGE WAS BEING LOADED INTO THE CARPUJECT HOLDER, THE DEVICE "COLLAPSED" IN THE PT'S HAND. ON (B)(6) 2013, THE PT REPORTED THAT THE HEPARIN THERAPY WAS NOT ADMINISTERED. ON (B)(6) 2013, THE DEVICE WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475170 WNTHRP CPJT HOLDERS 2ML/5ML (F) 80IQG IQG HOSPIRA, INC. NA UNKLL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HEPARIN SODIUM 5,000 UNITS/0.5 ML: LIST #01316| LOT #24640LL, MFR HOSPIRA, INC.