BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2891129 · Received November 14, 2012

    Report

    Report Number
    9616066-2012-00789
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS THE SET WAS DISCARDED. THE CUSTOMER REPORT OF BLOOD LEAKED FROM CAP COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, " WHILE DRAWING LABS FROM PICC LINE, BLOOD FROM THE END OF THE CAP SOILED RN'S GLOVES. PATIENT IS IN ISOLATION FOR SHINGLES." THERE WAS NO REPORT OR PATIENT/STAFF HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE: UNKNOWN| SYRINGE, MFR/MODEL/LOT UNKNOWN