BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 4214086 · Received August 6, 2014

    Report

    Report Number
    9616066-2014-00749
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 17, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 08/06/2014. (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IN THE OUTPATIENT ONCOLOGY UNIT, THE NURSE WAS FLUSHING POST DRAW, AND THE SYRINGE "POPPED OFF" THE MAXZERO, SPRAYING HER IN THE FACE WITH BLOOD AND FLUID. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459103 MAXZERO NEEDLELESS CONNECTOR IV SET CONNECTOR FPA CAREFUSION CORPORATION MZ1000-07 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 12538-28 WITH CLAVE PORT, CLAVE Y-SITE, 103 INCH,| COVIDIEN PRE-FILLED SALINE SYRINGE, MODEL/LOT UNK| WALKMED TUBING SET, REF. PS-360/10, LOT UNK.| HOSPIRA LIFESHIELD PRIMARY PLUMSET LIST NO.,| BARD, MINILOC SAFETY INFUSION SET, REF. 0632034,| HUBER NEEDLE, 20 GAUGE BY 0.75 IN, MODEL/LOTS UNK,| NON-DEHP, MODEL/LOT UNK