BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100

    MDR report key: 17821594 · Received September 26, 2023

    Report

    Report Number
    3003152976-2023-00420
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 11, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 8880884 FOLLOW UP MDR FOR DEVICE EVALUATION: ONE UNUSED SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE DEVICE TO AN INFUSION BAG WITH LIQUID IN ATTEMPT TO RECREATE THE REPORTED INCIDENT. IT WAS FOUND THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGE FROM THE INFUSION ADAPTER WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2102211, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON ANY OF THE INFUSION ADAPTERS. LEAKAGE TESTING WAS PERFORMED AND IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGE WAS OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL RETAINED SAMPLES ALONG WITH THE RETURNED PRODUCT UNDERWENT THESE EVALUATIONS AND PRODUCT WAS VERIFIED TO MEET REQUIRED LIMITS, INCLUDING PROPER SPIKE LENGTH AND DIAMETER. BASED ON THE AVAILABLE INFORMATION AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO ENSURE ALL CONNECTIONS ARE SECURE WHEN USING THIS PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED CHEMOTHERAPY MEDICATION FROM THE INTERFACE PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING OF CHEMOTHERAPY DRUG FROM INTERFACE PORT OF RUBBER PORT OF IV BAG AND BD INFUSION ADAPTOR." THERE WAS NO IMPACT ON PATIENT/HCP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INFUSION ADAPTER C100 LEAKED CHEMOTHERAPY MEDICATION FROM THE INTERFACE PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING OF CHEMOTHERAPY DRUG FROM INTERFACE PORT OF RUBBER PORT OF IV BAG AND BD INFUSION ADAPTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097683 BD PHASEAL¿ INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2102211 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown