BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONNECTOR(500/CS)

    MDR report key: 1579184 · Received December 16, 2009

    Report

    Report Number
    9613251-2009-00269
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    November 1, 2009
    Report Date
    November 25, 2009
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11572. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND HAS A 510K OF K063239. 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. THE EXTENSION SET WAS CONNECTED TO THE PATIENT'S IV CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION AT AN UNSPECIFIED RATE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE EXTENSION SET HAD DISCONNECTED FROM THE IV CATHETER, AND AN UNSPECIFIED VOLUME OF SOLUTION HAD LEAKED. THE EXTENSION SET WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH T-CONNECTOR(500/CS) UNK FPA HOSPIRA, LTD. NA 73130NY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED IV CATHETER, MANUFACTURER UNK