BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD PRE-SLIT INJECTION PORT

    MDR report key: 3150104 · Received April 25, 2013

    Report

    Report Number
    9616066-2013-00297
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 28, 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). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING FLUID AROUND THE BLUNT CANNULA WHILE FLUSHING THE SPLIT SEPTUM PORT. THIS OCCURRED IN THE CANTON INFUSION UNIT. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178820 MAXGUARD PRE-SLIT INJECTION PORT FPA CAREFUSION CORPORATION MY0240 13025150

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOSPIRA 18 GAUGE BLUNT CANNULA:| MODEL/LOT NUMBER UNKNOWN| BD SYRINGE: MODEL/LOT NUMBER UNKNOWN