BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 7442291 · Received April 18, 2018

    Report

    Report Number
    9616066-2018-00500
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 7, 2018
    Report Date
    April 11, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A LEAK OF UNASYN WHERE THE NON-BD CONNECTOR (DETERMINED TO BE A MICROCLAVE CONNECTOR) IS ATTACHED TO THE TUBING WAS CONFIRMED. VISUAL INSPECTION OBSERVED NO ANOMALIES. FUNCTIONAL TESTING WAS PERFORMED AND NO ANOMALIES OR LEAKING WAS OBSERVED. DIMENSIONAL ANALYSIS WAS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE LEAK WAS A SLIGHT GAP BETWEEN THE SYRINGE PSD MICROBORE SET FEMALE LUER AND THE NON-BD MICROCLAVE CONNECTOR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A UNASYN INFUSION A LEAK WAS NOTED BETWEEN THE MALE END OF THE NONBD CONNECTOR AND THE FEMALE LUER OF THE MICROBORE TUBING. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT MICRO CLAVE CONNECTOR, 10ML COVIDIEN SYRINGE WERE USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF UNASYN WHERE THE NONBD CONNECTOR IS ATTACHED TO THE TUBING WHILE CONNECTED TO A PATIENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283751 ALARIS SYRINGE MODULE SET, ADMINISTRATION, INTRAVASCUALAR FPA CAREFUSION 10014914

    Patients

    Seq Age Sex Outcome Treatment
    1 8015,ME1250,8110, TD (B)(6) 2018| SYRINGE, MICRO CLAVE CONNECTOR.| 8015,ME1250,8110, TD (B)(6) 2018