BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT IV ADMINISTRATION SET

    MDR report key: 3063133 · Received April 11, 2013

    Report

    Report Number
    1649914-2013-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BECAUSE THE SAMPLE HAD CONTAINED A CHEMOTHERAPY AGENT (S), IT COULD NOT BE DECONTAMINATED OR RETURNED TO THE MFR FOR ANALYSIS. THE SAMPLE WAS VISUALLY OBSERVED WHILE REMAINING IN THE BIOHAZARD BAG. PHOTOS AND VISUAL INSPECTION CONFIRMED FLUID LEAKING FROM THE TOP OF THE SPLIT SEPTUM. QUEST MEDICAL, INC HAD ALREADY INITIATED AN INVESTIGATION ON THIS ALLEGED ISSUE AND THIS EVENT IS ADDED TO THAT INVESTIGATION. QUEST MEDICAL, INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DURING A SITE VISIT TO THE HOSPITAL, QUEST EMPLOYEES WERE SHOWN A BIOHAZARD BAG CONTAINING THIS Q2 MULTIPORT IV ADMINISTRATION SET WITH AN ALLEGED LEAK. THE HOSP ADMINISTRATOR DID NOT HAVE ANY INFO ON THE CIRCUMSTANCES OR EVENTS LEADING TO THE DISCOVERY OF THE PRODUCT ISSUE OR EVENT WHICH DEPARTMENT IT ORIGINATED FROM. A NOTE ON THE BAG INDICATED THAT A LOWER PORT LEAKED CHEMOTHERAPY AGENT WHEN AN IV PUSH WAS ADMINISTERED. DUE TO CONTACT WITH CHEMOTHERAPY AGENT (S), THE SAMPLE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. THE LOT NUMBER IS UNK. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156131 Q2 MULTIPORT IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention