BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET

    MDR report key: 6133731 · Received November 29, 2016

    Report

    Report Number
    9616066-2016-01680
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 8, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADAPTER; 10ML BD SYRINGE REF (B)(4), LOT 6050864, EXP (B)(6) 2019, 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    8100; TD (B)(6) 2016. THE CUSTOMER¿S REPORT OF THE TUBING LEAKING WAS CONFIRMED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN LEAKING AT THE CONNECTION BETWEEN THE CONCOMITANT NEEDLE FREE VALVE AND THE FEMALE LUER ON THE EXTENSION SET. DIMENSIONAL TESTING WAS PERFORMED AND ALL DIMENSIONS WERE WITHIN SPECIFICATIONS. NO STRESS/ TOOL MARKS WERE OBSERVED. NO LEAKING WAS OBSERVED AFTER TIGHTENING THE CONNECTIONS. THE PROBABLE CAUSE OF THE LEAK WAS THE CONNECTION BETWEEN THE NEEDLE FREE VALVE AND THE EXTENSION SET NOT BEING COMPLETELY TIGHTENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN INFUSION OF METHYLPREDNISOLONE AND RITUXIMAB, THE CLINICIAN FLICKED THE TUBING TO CAUSE AIR BUBBLES TO RISE, WHEN THE TUBING STARTED TO LEAK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783917 MICROBORE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 30914

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)