BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 8962890 · Received September 4, 2019

    Report

    Report Number
    9616066-2019-02485
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 7, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403236242
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE SALINE FLUSH SYRINGE TIP BROKE OFF IN THE EXTENSION TUBING WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. INSPECTION OBSERVED THAT THE SYRINGE TIP WAS BROKEN OFF AND WAS LODGED WITHIN THE EXTENSION SET'S FEMALE LUER END. CLEAR FLUID WAS ALSO OBSERVED IN THE TUBING THROUGHOUT THE SET. CLOSER INSPECTION UNDER A LAB MICROSCOPE OBSERVED SIGNS OF STRESS MARKS ON THE SURFACES OF THE SYRINGE BREAKAGE HOWEVER, NO ANOMALIES OR DAMAGE WERE OBSERVED ON THE EXTENSION SET MODEL ME2017. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BREAKAGE OF THE SYRINGE¿S MALE LUER TIP LODGED INSIDE THE EXTENSION SET¿S FEMALE LUER. THE ROOT CAUSE THAT THE SYRINGE TIP BROKE OFF IN THE EXTENSION TUBING WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SALINE FLUSH SYRINGE TIP BROKE OFF IN THE EXTENSION TUBING WHEN CHANGING THE SYRINGE OUT. THE CUSTOMER STATES THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 10ML BD SYRINGE, LOT: 9113775, EXP: 2022-04-30, 0.9% SODIUM CHLORIDE INJECTION, THERAPY DATE: (B)(6) 2019. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALINE FLUSH SYRINGE TIP BROKE OFF IN THE EXTENSION TUBING. THE CUSTOMER STATES THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753673 MAXGUARD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION ME2017 10885403236242

    Patients

    Seq Age Sex Outcome Treatment
    1