BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100

    MDR report key: 8713128 · Received June 19, 2019

    Report

    Report Number
    3003152976-2019-00406
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 13, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS, ONE VIDEO, AND A SAMPLE FROM LOT 1903101 WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. FUNCTIONAL TESTING COMPLETED ON THE RETURNED SAMPLE FOUND THE PRODUCT FUNCTIONED AS INTENDED, NO ISSUES WERE IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 1903101 AND 1704107, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. PER THE PHOTO, SEMI-RIGID CONTAINERS WERE USED DURING THE INFUSION. THIS CONTAINER MUST BE VENTED IN ORDER TO PROPERLY EMPTY THE CONTENTS. IN REVIEWING THE VIDEO, THE INFUSION ADAPTER WAS USED WITH VENTED IV TUBING, HOWEVER, THE AIR INLET WAS CLOSED. SEMI-RIGID CONTAINERS THAT ARE ACCESSED WITH NON-VENTED IV TUBING CREATE A NEGATIVE PRESSURE THAT CAN INTERFERE WITH THE FLOW OF IV SOLUTIONS, NOT ALLOWING THE FULL CONTENTS OF THE CONTAINER TO EMPTY PROPERLY. WHILE THE CONTAINERS REQUIRE A VENTED IV LINE, PER THE INSTRUCTIONS FOR USE INCLUDED WITH THE PRODUCT, PHASEAL C100 SHOULD NOT BE USED WITH VENTED IV TUBING OR AN OPEN VENT AS THIS CREATES THE POTENTIAL FOR EXPOSURE TO HAZARDOUS MEDICATIONS. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE WHEN USING PHASEAL DEVICES TO ENSURE THE PRODUCT FUNCTIONS AS INTENDED. BASED ON THE RESULTS OF OUR INVESTIGATION, OUR MANUFACTURING PROCESS DID NOT CONTRIBUTE TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE BD PHASEAL¿ INFUSION ADAPTER C100 WAS ASSEMBLED ONTO THE BBRAUN 0.9 NACL OR HEMOFARM 0.9% NACL, THE INFUSION STOPPED AFTER A TIME AND "ABOUT 10 -20 ML" OF SOLUTION WAS NOT RELEASED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE ADAPTER C100 IS ASSEMBLED ON IV PLASTIC BOTTLE (BBRAUN 0.9 NACL OR HEMOFARM 0.9% NACL), THE LEAKING OF THE INFUSION SOLUTION STOPS AFTER SOME TIME. USUALLY, ABOUT 10 -20 ML OF IV BOTTLE SOLUTION CANNOT BE RELEASED. THIS HAPPENS APPROXIMATELY ON EVERY FIFTH OF THE IV BOTTLE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE BD PHASEAL¿ INFUSION ADAPTER C100 WAS ASSEMBLED ONTO THE BBRAUN 0.9 NACL OR HEMOFARM 0.9% NACL, THE INFUSION STOPPED AFTER A TIME AND "ABOUT 10 -20 ML" OF SOLUTION WAS NOT RELEASED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE ADAPTER C100 IS ASSEMBLED ON IV PLASTIC BOTTLE (BBRAUN 0.9 NACL OR HEMOFARM 0.9% NACL), THE LEAKING OF THE INFUSION SOLUTION STOPS AFTER SOME TIME. USUALLY, ABOUT 10 -20 ML OF IV BOTTLE SOLUTION CANNOT BE RELEASED. THIS HAPPENS APPROXIMATELY ON EVERY FIFTH OF THE IV BOTTLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505240 BD PHASEAL¿ INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1903101 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other