BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD EXTENSION LINE

    MDR report key: 2997200 · Received March 5, 2013

    Report

    Report Number
    1649914-2013-00004
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1 OF 5. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1 OF 5. 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

    IT WAS REPORTED BY THE HOSPITAL NURSING PERSONNEL THAT THEY EXPERIENCED AN ISSUE WITH THE MODEL 9520. THEY REPORTED THAT WHILE USING THE DEVICE TO DELIVER CHEMOTHERAPY IN THEIR (B)(6) HOSPITAL, ONE OF THE BLUE PORTS DETACHED FROM THE SET. THE INITIAL REPORTER INDICATED THIS ISSUE HAS OCCURRED FIVE TIMES (SPECIFIC DATA NOT AVAILABLE FOR ALL OCCURRENCES). FOR THIS ONE OCCURRENCE, THE PT DID NOT RECEIVE THE REMAINING 3ML OF THE CHEMOTHERAPY AGENT. THERE WAS NO SPILLAGE OR USER CONTAMINATION REPORTED. IT WAS REPORTED THAT THE TUBING WAS CLAMPED AND A NEW BAG/SET SUCCESSFULLY INSTALLED. THERE WERE NO RESULTANT PT COMPLICATIONS FROM THE ALLEGED ISSUE. THE HOSPITAL WAS UNABLE TO RETURN ANY DEVICE SAMPLES DUE TO THE USE OF CHEMOTHERAPY AGENTS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93734 Q2 MULTIPORT MANIFOLD EXTENSION LINE IV EXTENSION TUBING KITS FPA QUEST MEDICAL, INC. 9520 0430822N04

    Patients

    Seq Age Sex Outcome Treatment
    1