BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD PRE-SLIT INJECTION PORT

    MDR report key: 3133716 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00337
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORTED BY THE MFR. THE AFFECTED PRODUCT HAS BEEN REC'D AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAKING SPLIT SEPTUM PORT WHILE ON A PT. THERE WAS NO PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191053 MAXGUARD PRE-SLIT INJECTION PORT FPA CAREFUSION CORPORATION MY0240 13016409

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR