BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONNECTOR (500/CS)

    MDR report key: 1679283 · Received May 3, 2010

    Report

    Report Number
    9613251-2010-00046
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 8, 2010
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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 SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AND UNSPECIFIED LENGTH OF TIME IN USE, THE YELLOW FEMALE LUER LOCK ADAPTER SEPARATED FROM THE TUBING; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE VOLUME OF BLOOD LOSS WAS REPORTED AS "A SMALL AMOUNT." THE TUBING SET WAS REPLACED 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 EXTENSION SET WITH T-CONNECTOR (500/CS) UNK FPK HOSPIRA, LTD NA 75092NY

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR