BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD PRE SLIT INJECTION POERT

    MDR report key: 3063268 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00209
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED. THE SPLIT SEPTUM PORT USED IN THIS EVENT WAS DISCARDED BY THE CUSTOMER. THE REPORT THAT THE SPLIT SEPTUM LEAKED COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FORM THE SEPTUM. THE NURSE WAS FLUSHING THE PORT WITH NORMAL SALINE WHEN IT STARTED TO LEAK. THE NURSE COULD VISUALLY SEE THE PORT HAD AN "OPEN" SLIT IN THE SEPTUM AND THAT IS WHERE THE FLUID WAS LEAKING. THE CUSTOMER CONFIRMED THAT NO PT/NURSE HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125177 MAXGUARD PRE SLIT INJECTION POERT FPA CAREFUSION CORP MY0240 13016935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SHIELD BLUNT, REFERENCE NUMBER (B)(4)| HOSPIRA BLUNT CANNULA - KENDALL MONO JET LIFE