BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE EXTENSION SET

    MDR report key: 3944194 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00460
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE EXTENSION SET SEPARATED FROM THE SMITH'S MEDICAL CATHETER DURING A PRESSURE INJECTION IN CT. NO PATIENT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274984 SMALLBORE EXTENSION SET FPA CAREFUSION CORPORATION 20041E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SMITH'S MEDICAL CATHETER, MODEL/LOT: UNK