BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 10 INCH EXT W/ 0.2 PED & VLV PORT

    MDR report key: 9340710 · Received November 19, 2019

    Report

    Report Number
    9616066-2019-03329
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 19, 2019
    Report Date
    October 30, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM D11-10ML BD SYRINGE LOT 9150969 EXP 2022-04-30, 0.9% SODIUM CHLORIDE INJECTION PRODUCT GRID REVISED FROM PRI TUBING TO: 20029E. ADDITIONAL INFORMATION ADDED TO: A1, A2, A3, B3, B7, D1, D4, D10, G5. CORRECTION; H.6. (PATIENT CODE). THE CUSTOMER REPORT THAT THE FILTER CRACKED AND LEAKED WAS NOT CONFIRMED BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING. THE SAMPLES WERE RECEIVED ATTACHED TO EACH OTHER: SYRINGE TO NON-BD LUER CONNECTOR, NON-BD LUER CONNECTOR TO 30914, AND 30914 TO 20029E. FUNCTIONAL TESTING WAS PERFORMED BY PUSHING THE REMAINING FLUID, NO LEAK OR ISSUE WAS OBSERVED. THE SYRINGE WAS CAREFULLY DETACHED. INSPECTION UNDER MAGNIFICATION OF THE RECENTLY MATED COMPONENTS OBSERVED NO DAMAGES OR ISSUES. THE SYRINGE WAS ALSO FILLED AND THE FLUID PUSH WAS REPEATED, NO LEAK OR ISSUE WAS STILL OBSERVED. AN INFUSION WAS PROGRAMMED AT A RATE OF 5ML FOR ONE HOUR. NO LEAK WAS OBSERVED AND THE INFUSION COMPLETED AS EXPECTED WITH NO ALARM OR ANY ISSUE. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INFUSION OF FENTANYL, PRECEDEX, AND CALCIUM THE FILTER CRACKED AND LEAKED THE MEDICATION WHICH CAUSED DELAY IN TREATMENT. IT WAS FURTHER STATED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING CRACKED/BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136287 ALARIS 10 INCH EXT W/ 0.2 PED & VLV PORT SET, ADMINISTRATION, INFUSION FPA CAREFUSION 20029E

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO NON-BD SYRINGE CONNECTOR,30914,TD: (B)(6) 2019.