BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 10 INCH EXT W/ 0.2 PED & VLV PORT

    MDR report key: 9340708 · Received November 19, 2019

    Report

    Report Number
    9616066-2019-03327
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 22, 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 SYRINGES LOT 9175822 EXP 2022-06-30, 0.9% SODIUM CHLORIDE INJECTION. PRODUCT GRID REVISED-SUSPECT CHANGED FROM PRI TUBING TO 20029E. ADDITIONAL INFORMATION ADDED TO: A1, A2, A3, B3, B7, D1, D4, D10, D11, G5, & H.6. (DEVICE CODE). CORRECTION; H.6. (PATIENT CODE). THE CUSTOMER REPORT THAT TUBING SET CRACKED WAS NOT CONFIRMED. VISUAL INSPECTION OBSERVED NO DAMAGE. HOWEVER THE SET'S MICRON FILTER'S AIR VENT MEMBRANE WAS WETTED/COMPROMISED AND FUNCTIONAL TESTING OBSERVED A LEAK (TERMED ¿WEEPING OUT¿) FROM THE SAME AREA. THE SAMPLES WERE RECEIVED ATTACHED TO EACH OTHER: SYRINGE 1 TO NON-BD LUER CONNECTOR 1, NON-BD LUER CONNECTOR 1 TO 30914 1, 30914 1 TO SMART SITE OF 20029E, SYRINGE 2 TO NON-BD LUER CONNECTOR 2, NON-BD LUER CONNECTOR 2 TO 30914 2, 30914 2 TO 20029E. THE SET WAS INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED BY PUSHING FLUID THROUGH FROM BOTH SYRINGES. IT WAS OBSERVED THAT FLUID LEAKED OUT FROM THE FILTER VENT. NO OTHER LEAK WAS OBSERVED. THE ROOT CAUSE OF THE OBSERVED LEAK FROM THE FILTER VENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INFUSION THE TUBING SET CRACKED AND LEAKED INTO THE PATIENTS BED WHICH CAUSED DELAY. ALTHOUGH THE CUSTOMER STATED THAT THERE WAS A DELAY IN TREATMENT, THERE WAS NO IMPACT TO THE INFANT PATIENT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED BUT NOT PROVIDED. 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
    1136290 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 2 NON-BD SYRINGE CONNECTORS, 30914, TD (B)(6) 2019.