BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP MACRO 30IN EXT

    MDR report key: 1944163 · Received December 6, 2010

    Report

    Report Number
    9613251-2010-00175
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE EXTENSION SET WAS BEING USED TO DELIVER AN UNSPECIFIED ANESTHETIC MEDICATION. THE MALE ADAPTER OF A STOPCOCK WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION SET. THE MALE ADAPTER OF THE EXTENSION SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE PATIENT'S 20 GAUGE IV CATHETER. IT WAS REPORTED THAT WHEN THE ANESTHESIOLOGIST WAS DELIVERING A BOLUS OF MEDICATION THROUGH THE STOPCOCK, THE MALE ADAPTER OF THE EXTENSION SET "POPPED OFF" FROM THE IV CATHETER. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. IT WAS REPORTED THAT THE ANESTHESIOLOGIST RECONNECTED THE MALE ADAPTER OF THE EXTENSION SET TO THE IV CATHETER, TAPED THE CONNECTION, AND THE THERAPY WAS RESUMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP MACRO 30IN EXT 80FPK FPK HOSPIRA, LTD NA 90205NS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 20 GAUGE IV SAFETY CATHETER| MFG BY BECTON DICKINSON