BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD ADMINISTRATION SET

    MDR report key: 2961054 · Received January 16, 2013

    Report

    Report Number
    9616066-2013-00025
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    December 27, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BIOMED REPORTED A SET LEAKED DURING AN INFUSION ON A NICU PATIENT. HE DOES NOT HAVE ANY SPECIFIC PATIENT OR EVENT DETAILS. AFTER THE EVENT STAFF NOTED THERE WAS A HAIRLINE CRACK IN THE MIDDLE PORT OF THE STOPCOCK PARALLEL TO THE STEM. THERE WAS NO HARM TO THE PATIENT OR MEDICAL INTERVENTION REQUIRED. THE CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24113 MAXGUARD ADMINISTRATION SET FPA CAREFUSION CORP MX9435 12116055

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK