BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET

    MDR report key: 6037669 · Received October 18, 2016

    Report

    Report Number
    1649914-2016-00049
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 27, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPK
    UDI-DI
    00634624957114
    PMA / PMN Number
    K800825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT RETURNED ONE DEVICE SAMPLE OUT OF THE PACKAGE AND SIX OTHER DEVICES (SAME LOT) STILL SEALED IN THEIR PACKAGES. THE ONE DEVICE SAMPLE APPEARED TO HAVE NOT BEEN USED. VISUAL EXAMINATION OF THE DEVICE FOUND NO ANOMALIES. ALL SEVEN SAMPLES WERE PRIMED WTIH WATER USING A 20 CC SYRINGE, TO SIMILATE THE CONDITIONS STATED BY THE USER. NONE OF THE SAMPLES LEAKED OR SQUIRTED WATER FROM THE PORT PER THE COMPLAINT. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHEN USING THE IV ADMINISTRATION EXTENSION SET. THE REPORT STATED THAT A 20CC LUER LOCK SYRINGE FULL OF BLOOD WAS ATTACHED TO ONE OF THE DEVICE PORTS, AND UPON INJECTION INTO THE PORT BLOOD SQUIRTED OUT OF ANOTHER PORT. THE REPORT STATED THE DEVICE WAS DISCARDED AND ANOTHER MANIFOLD WAS USED. THE PATIENT WAS 5 MONTHS OLD AND THE IV LINE WAS ATTACHED TO AN INTERNAL JUGULAR CENTRAL LINE. THE COMPLAINANT STATED THERE WAS NO HARM CAUSED TO THE PATIENT BUT THAT THE ISSUE HAD OCCURREC IN THREE DIFFERENT PROCEDURES. THE COMPLAINANT CHOSE TO RETURN SEVEN OF THE UNUSED DEVICE TO THE DISTRIBUTOR FOR ANALYSIS BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687982 Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET INTRAVASCULAR ADMINISTRATION EXTENSION SET FPK QUEST MEDICAL, INC. 95711 0489865Y03 00634624957114

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention