BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD T-CONNECTOR EXTENSION SET

    MDR report key: 2961049 · Received January 16, 2013

    Report

    Report Number
    9616066-2013-00016
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION INFORMATION SHOULD THE DEVICE BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MEDWATCH REPORT EVENT DESCRIPTION: PATIENT WAS RECEIVING IV CONTRAST VIA THE DISTAL PORT OF A MAXGUARD PRESSURE RATED T-CONNECTOR ON A PATENT 18 GUAGE IV CATHETER. THE PROXIMAL PORT BLEW OUT AND CONTRAST SPRAYED ONTO FLOOR. WHEN CT TECH DISCONNECTED DISTAL PROXIMAL PORT PATIENT BLED THROUGH PROXIMAL PORT. ONCE THE DEVICE WAS REPLACED, THE IV WORKED AS DESIGNED AND THE CT PROCEEDED WITHOUT FURTHER INCIDENT. 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
    23913 MAXGUARD T-CONNECTOR EXTENSION SET FPA CAREFUSION CORP MPXT1001-C 12066565

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR 18 GAUGE IV CATHETER, MFR/MODEL/LOT UNK