BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2082803 · Received April 29, 2011

    Report

    Report Number
    3005748548-2011-00013
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MALE LUER OF THE MAXPLUS CONNECTOR CONFORMED TO SPECIFICATION AND CONNECTOR PASSED HIGH PRESSURE LEAKAGE TESTING, IT IS CONCLUDED THAT THE MAXPLUS CONNECTOR DID NOT CONTRIBUTE TO THE REPORTED LEAKAGE ISSUE BY CUSTOMER. WE WERE UNABLE TO DETERMINE THE ACTUAL ROOT CAUSE OF THE REPORTED ISSUE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY HAVE HAD ISSUES WHEN POWER INJECTING THROUGH THE MAXPLUS. THEY ARE CONNECTING THE MAXPLUS TO THE HUB OF THE CATHETER AND SECURING WITH TAPE AND TEGADERM. THERE IS NO FAILURE OF THE MAXPLUS ITSELF, BUT IT COMES LOOSE FROM THE HUB OF THE CATHETER AND CAUSES CONTRAST TO LEAK. NO HARM TO PT OR CLINICIAN REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORP MP1000-C MV051332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT # UNK| MEDRAD, SMITHS JELCO POWER INJECTOR TUBING: