BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7679556 · Received July 11, 2018

    Report

    Report Number
    9616066-2018-01000
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 9, 2018
    Report Date
    June 19, 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

    CONCOMITANT MEDICAL PRODUCTS: (2)MZ1000-07; NON-BD BIFUSE EXTENSION SET; 10ML BD POSIFLUSH SYRINGE (REF (B)(4), LOT #8073953, EXP. 2121-03-31) CONTAINING 3ML OF 0.9% SODIUM CHLORIDE INJ.; NON-BD 3-WAY STOPCOCK. THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. FUNCTIONAL TESTING SHOWED A LEAK AT THE CONNECTION OF THE DISTAL MAXZERO CONNECTOR TO THE MATING SYRINGE. FURTHER INSPECTION UNDER MAGNIFICATION SHOWED A MICROCHANNEL ON THE INTERIOR WALL OF THE LEAKING MAXZERO CONNECTOR. THE ROOT CAUSE OF THE MICROCHANNEL THAT CREATES A FLUID PATH IS A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NOTICING A WET SPOT ON THE PATIENT'S LINEN THAT APPEARED TO BE UNDER THE CVP/MEDLINE OF THE CVL. THEY FLUSHED THE CVP LINE WITH 2 ML OF SODIUM CHLORIDE AND NO LEAKS WERE NOTED. THE TUBING AND NEEDLELESS CONNECTOR APPEARED TO BE FREE OF CRACKS. AFTER THE CLINICIAN PLACED GAUZE UNDERNEATH THE TUBING, THEY NOTICED THE GAUZE APPEARED BOTH SLIGHTLY DAMP AND BLOOD TINGED IN COLOR UNDERNEATH THE BROWN LUMEN OF CVL. THEY PERFORMED A CAP CHANGE TO THE BROWN LUMEN AND CHANGED OUT ALL TUBING ON THE BROWN LUMEN LINE. A LEAK WAS NOTED AT THE CONNECTION OF THE Y TUBING AND THE CONNECTOR CAP. 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 NOTICING A WET SPOT ON THE PATIENT'S LINEN THAT APPEARED TO BE UNDER THE CVP/MEDLINE OF THE CVL. THEY FLUSHED THE CVP LINE WITH 2 ML OF SODIUM CHLORIDE AND NO LEAKS WERE NOTED. THE TUBING AND NEEDLESS CONNECTOR APPEARED TO BE FREE OF CRACKS. AFTER THE CLINICIAN PLACED GAUZE UNDERNEATH THE TUBING, THEY NOTICED THE GAUZE APPEARED BOTH SLIGHTLY DAMP AND BLOOD TINGED IN COLOR UNDERNEATH THE BROWN LUMEN OF CVL. THEY PERFORMED A CAP CHANGE TO THE BROWN LUMEN AND CHANGED OUT ALL TUBING ON THE BROWN LUMEN LINE. A LEAK WAS NOTED AT THE CONNECTION OF THE Y TUBING AND THE CONNECTOR CAP. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519528 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230608

    Patients

    Seq Age Sex Outcome Treatment
    1 CV CATHETER, THERAPY DATE (B)(6) 2018