BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MNBR EXT 59IN NDHP

    MDR report key: 1944201 · Received December 6, 2010

    Report

    Report Number
    9613251-2010-00171
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IT WAS REPORTED THAT THE FEMALE LUER OF THE EXTENSION SET WAS CONNECTED TO THE MALE ADAPTER OF A 60ML SYRINGE, TO DELIVER 50ML FOR AN UNSPECIFIED MEDICATION VIA A SYRINGE PUMP, AT AN UNSPECIFIED RATE. IT WAS REPORTED AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE FEMALE LUER OF THE EXTENSION SET "LUER OFF" OF THE MALE ADAPTER OF THE SYRINGE AND DISCONNECTED. THE EXTENSION SET WAS REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT THE NURSE TAPED THE CONNECTION OF THE EXTENSION SET AND THE SYRINGE. 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 MNBR EXT 59IN NDHP 80FPK FPK HOSPIRA, LTD NA 92097NS

    Patients

    Seq Age Sex Outcome Treatment
    1 60ML LUER-LOK SYRINGE, (B)(4)| MEDFUSION SYRINGE PUMP, (B)(4)