BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2082836 · Received April 29, 2011

    Report

    Report Number
    3005748548-2011-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF FLOW PROBLEM AND DIFFICULT TO PRIME WAS NOT CONFIRMED. TESTING RESULTS INDICATED THAT DEVICE DID PRIME BUT FLOW RATE WAS AT LOW END OF SPECIFICATION. THE MATING LUER WAS NOT SUPPLIED AND IS NOT KNOWN. A TEST MALE LUER WHICH WAS USED DID CREATE A SITUATION THAT TWISTED AND PARTIALLY BLOCKED THE VALVE, HOWEVER BECAUSE THE MATING LUER DEVICE WAS NOT SUPPLIED AND IS NOT KNOWN, IT IS NOT POSSIBLE TO KNOW WHETHER THE MATING PART INFLUENCED THE BLOOD INFUSION RATE. THE CAUSE OF THE CUSTOMER'S REPORTED PROBLEM IS UNDETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATED THEY COULDN'T GET A BLOOD RETURN THROUGH THE IV CONNECTOR ON A PICC LINE. ONCE THEY REMOVED THE CONNECTOR AND WENT STRAIGHT TO THE HUB THEY GOT A RETURN. WHEN TRYING TO FLUSH THE CONNECTOR, THE CONNECTOR DID NOT FLUSH NORMALLY. NO REPORT OF HARM TO PT OR CLINICIAN. NO ADDITIONAL PT DETAILS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LUER LOCK PRE-FILLED NORMAL SALINE SYRINGE