BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN PICC

    MDR report key: 3147125 · Received March 18, 2013

    Report

    Report Number
    3005060859-2013-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    March 18, 2013
    Manufacturer
    MARIAN MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    050542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REC'D NOTIFICATION OF INCIDENT ON 2/19/013 FROM FDA MED WATCH REPORT (B)(4). TRY TO MAKE CONTACT (B)(6) ON 2/19/2013 AND LEFT MESSAGE. MADE IMMEDIATE CONTACT WITH (B)(6) ON 2/19/2013 IN NICU AND SHE STATED (B)(6) WAS CLINICIAN WHO PLACED PICC LINE. (B)(6) HAS NOT ATTENDED TRAINING IN-SERVICE FOR THIS PRODUCT. TRIED CONTACTING (B)(6), RISK MANAGER ON 3/1/2013 AND LEFT VOICE MAIL MESSAGE TO GATHER ADD'L INFO. CONTACTED AGAIN ON 3/5/2013 AND LEFT VOICE MAIL MESSAGE. CONTACTED FOR FOURTH TIME ON 3/8/2013 AND LEFT VOICE MAIL MESSAGE INDICATING THIS WAS FOURTH ATTEMPT TO CONNECT WITH (B)(6) AND OBTAIN ADD'L INFO REGARDING INCIDENT. NO RESPONSE OR RETURN CALL FROM (B)(6) TO DATE. MARIAN MEDICAL WILL NO LONGER SELL TO THIS INSTITUTION. HOLDING ORDERS TO HOSPITAL UNTIL RESPONSE FROM RISK MANAGER OR IN-SERVICE OR TRAINING TO PERSONAL IN QUESTION IS COMPLETED.

    Description of Event or Problem · 1

    ONLY INFO AVAILABLE: PICC LINE NOTED TO BE LEAKING DURING ROUTING MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112429 GUARDIAN PICC PICC LINE LJS MARIAN MEDICAL, INC. PICC-2 12486

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK