BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 8649657 · Received May 29, 2019

    Report

    Report Number
    9616066-2019-01498
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 9, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403223228
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORT THAT THE VALVE PISTON DID NOT RECOIL (IDENTIFIED AS VALVE STICK DOWN) WAS CONFIRMED BASED ON FUNCTIONAL EVALUATION OF THE RECEIVED SAMPLES. THE ROOT CAUSE OF VALVE SLOW RETURN/STICK DOWN WAS IDENTIFIED AS A VALVE MOLDING ISSUE (MISMATCH OUT OF SPECIFICATION).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE UNSCREWING THE NS SYRINGE FROM THE CONNECTOR THE BLUE SPONGE INSIDE THE CONNECTOR DID NOT RECOIL CAUSING BLOOD TO SPURT OUT. THERE WAS NO HARM.

    Additional Manufacturer Narrative · 1

    NON-USED 10 ML BD SYRINGE LOT 9018633; NON USED 10 ML BD SYRINGE REF 302995; BD VACUTAINER REF 364902 LOT 8276553; NON-USED 10 ML AQUASTAT SYRINGE REF 250706 LOT KH04608; ONE NON-USED BARD PORT ACCESS KIT LOT REDN1499. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE UNSCREWING THE NS SYRINGE FROM THE CONNECTOR THE BLUE SPONGE INSIDE THE CONNECTOR DID NOT RECOIL CAUSING BLOOD TO SPURT OUT. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442542 MAXPLUS POSITIVE PRESSURE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MP1000-C 18116695 10885403223228

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE: (B)(6) 2019| THERAPY DATE: (B)(6) 2019