BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI)

    MDR report key: 12556878 · Received September 30, 2021

    Report

    Report Number
    3003152976-2021-00647
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150791
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2103501, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FOURTEEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED NO ISSUES OR DAMAGED OBSERVED. THICKNESS FROM THE IA PORT SEPTUM FROM ALL RETAINED SAMPLES WERE MEASURED BY METROLOGY TEAM AND DIMENSIONS MEET SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI) MEMBRANE WAS MISSING WHEN SPIKING IT INTO THE BAG, CAUSING CHEMOTHERAPY MEDICINE TO LEAK FROM THE TUBING PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CHECKING DOSE, DRUG WAS DRIPPING FROM PHASEAL ADAPTER SITE. 5-10 DROPS WAS CAUGHT BY CHEMO MAT. DOSE WAS DISCARDED. NEW DOSE WAS PREPARED FOR PATIENT. PHASEAL LOT NUMBER 2103501. AREA WAS CLEANED. SPILL DOCUMENTED." "THE PRODUCT INVOLVED IS THE C-100-O INFUSION ADAPTER THAT IS SPIKED INTO THE BAG PRIOR TO DISPENSING. THE LEAK CAME FROM THE PORT WHERE THE TUBING IS ATTACHED WHICH HAS A MEMBRANE PRIOR TO SPIKING. THIS ONE APPEARS TO BE DEFECTIVE IN THAT IT WAS MISSING AND THEREFORE CHEMO SPILLED OUT."

    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 THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI) MEMBRANE WAS MISSING WHEN SPIKING IT INTO THE BAG, CAUSING CHEMOTHERAPY MEDICINE TO LEAK FROM THE TUBING PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CHECKING DOSE, DRUG WAS DRIPPING FROM PHASEAL ADAPTER SITE. 5-10 DROPS WAS CAUGHT BY CHEMO MAT. DOSE WAS DISCARDED. NEW DOSE WAS PREPARED FOR PATIENT. PHASEAL LOT NUMBER 2103501. AREA WAS CLEANED. SPILL DOCUMENTED." "THE PRODUCT INVOLVED IS THE C-100-O INFUSION ADAPTER THAT IS SPIKED INTO THE BAG PRIOR TO DISPENSING. THE LEAK CAME FROM THE PORT WHERE THE TUBING IS ATTACHED WHICH HAS A MEMBRANE PRIOR TO SPIKING. THIS ONE APPEARS TO BE DEFECTIVE IN THAT IT WAS MISSING AND THEREFORE CHEMO SPILLED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454520 BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515079 2103501 00382905150791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown