BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE EXTENSION SET

    MDR report key: 3023245 · Received February 27, 2013

    Report

    Report Number
    9616066-2013-00130
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN REC'D. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FOUND FLUID LEAKING THROUGH THE FILTER AIR VENT HOLE. THERE WERE MULTIPLE INFUSIONS RUNNING THROUGH THE FILTER. THE IV SETS ARE CONNECTED WITH MULTIPLE TRI SET EXTENSIONS, WHICH ARE ATTACHED TO THE FILTER. NO PT HARM OR MEDICAL INTERVENTION REPORTED. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84936 SMALLBORE EXTENSION SET FPA CAREFUSION CORPORATION 10011865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACACIA TRIFURCATED EXTENSION SET: MODEL BG-004-05| MEDFUSION SYRIGNE PUMP: LOT UNK| ICU MEDICAL SYRINGE TUBING: MODEL B2141/LOT UNK| ICU MEDICAL IV CONNECTOR: MODEL MC100/LOT UNK| LOT UNK.