BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS INFUSION SET

    MDR report key: 6178833 · Received December 15, 2016

    Report

    Report Number
    9616066-2016-01846
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    December 2, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE MALE LUER TIP BREAKS OFF WAS CONFIRMED. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. DURING VISUAL INSPECTION IT WAS NOTED THAT PART OF THE TIP OF THE DISTAL MALE LUER ON THE PRIMARY SET WAS BROKEN OFF; WITH ONE SIDE SLIGHTLY HIGHER THAN THE OTHER. 0.1835 INCHES OF THE MALE LUER¿S TIP WAS MISSING. THE BROKEN OFF PIECE WAS NOT RECEIVED FROM THE CUSTOMER. FURTHER VISUAL INSPECTION OF THE DAMAGED COMPONENT UNDER MAGNIFICATION OBSERVED A WHITISH COLORED STRESS MARKING ON THE BROKEN LUER TIP'S LOWER SIDE. THERE WERE NO SIGNS OF DAMAGE OR DEFORMITIES FOUND ON THE REMAINING PORTION OF THE MALE LUER TIP OR COLLAR. RED DISCOLORATION WAS OBSERVED INSIDE THE BOTTOM 40 INCHES OF THE TUBING. NO OTHER ANOMALIES WERE OBSERVED ON THE CONCOMITANT PRIMARY SET. FUNCTIONAL TESTING RESULTED IN THE SET FLOWING FREELY AND RAN WITH NO ISSUES OBSERVED. PRESSURE TESTING CONFIRMED LEAKING FROM THE SETS OR ANY OF THEIR COMPONENTS. THE ROOT CAUSE OF THE MALE LUER TIP BREAKS OFF WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EXTENSION SET IS PLACED ONTO A STERILE FIELD AND WHEN THE SET IS CONNECTED TO THE MATING PRODUCT, THE MALE SPIN COLLAR BREAKS APART AND ON OCCASION THE MALE LUER TIP BREAKS OFF. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826584 ALARIS INFUSION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION 10942011

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), THERAPY DATE UNK