BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 6368845 · Received March 1, 2017

    Report

    Report Number
    9616066-2017-00378
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Report Date
    February 9, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-CFN EXTENSION SET; 10 ML BD SYRINGE, REF (B)(4), LOT: 6222983, LOT: 2019-07-31, 0.9% SODIUM CHLORIDE; 10 ML BD SYRINGE; THERAPY DATE UNKNOWN. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF A FLUID SPRAY WAS CONFIRMED. THE MAXZERO VALVE, NON-BD TUBING, AND CONCOMITANT SYRINGES WERE FUNCTIONING EFFECTIVELY THROUGHOUT TESTING WITH NO LEAKS NOTED. HOWEVER, THE SAFETY NEEDLE (UNKNOWN MANUFACTURER) ATTACHED TO THE NON-BD TUBING WAS OBSERVED TO BE SPRAYING FLUID IN DIFFERENT DIRECTIONS FROM 2 SEPARATE HOLES. THE CAUSE OF THE SPRAY WAS DETERMINED TO BE A DAMAGED SAFETY NEEDLE TIP. THE ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING CONNECTION BETWEEN INJECTION PORT DEVICE AND MATING SYRINGE FOR A BLOOD DRAW, SPRAY WAS NOTED ON THE NURSE¿S SLEEVE AND THE PATIENT¿S BEDDING. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152896 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE MATING PRODUCT, TD UNK