BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7720863 · Received July 25, 2018

    Report

    Report Number
    9616066-2018-01166
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    June 10, 2018
    Report Date
    July 9, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230608
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A FLUID LEAK WAS NEITHER CONFIRMED NOR REPLICATED. THE CUSTOMER-PROVIDED COMPONENTS WERE FUNCTIONING EFFECTIVELY DURING THE INVESTIGATION. NO INDICATIONS OF A LEAK SITE WERE OBSERVED ANYWHERE ALONG THE TUBING CONFIGURATION. THE ROOT CAUSE OF THE REPORTED FAILURE WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RN TIGHTENED THE SLIGHTLY LOOSE CONNECTION OF THE TUBING WHICH RESOLVED A SMALL LEAK. LATER THAT DAY, THE RN NOTED A WET SPOT ON THE PGE LINE CONNECTION TO THE Y-SITE TUBING. THE SYRINGE, CAP AND TUBING WERE REPLACED. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RN TIGHTENED THE SLIGHTLY LOOSE CONNECTION OF THE TUBING WHICH RESOLVED A SMALL LEAK. LATER THAT DAY, THE RN NOTED A WET SPOT ON THE PGE LINE CONNECTION TO THE Y-SITE TUBING. THE SYRINGE, CAP AND TUBING WERE REPLACED. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RN TIGHTENED THE SLIGHTLY LOOSE CONNECTION OF THE TUBING WHICH RESOLVED A SMALL LEAK. LATER THAT DAY, THE RN NOTED A WET SPOT ON THE PGE LINE CONNECTION TO THE Y-SITE TUBING. THE SYRINGE, CAP AND TUBING WERE REPLACED. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RN TIGHTENED THE SLIGHTLY LOOSE CONNECTION OF THE TUBING WHICH RESOLVED A SMALL LEAK. LATER THAT DAY, THE RN NOTED A WET SPOT ON THE PGE LINE CONNECTION TO THE Y-SITE TUBING. THE SYRINGE, CAP AND TUBING WERE REPLACED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559657 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230608

    Patients

    Seq Age Sex Outcome Treatment
    1 MZ1000-07, SYRINGE, THERAPY DATE: (B)(6) 2018| MZ5307,MZ5305, MZ9226, NON-BD EXT SET