BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INFUSION ADAPTER (C100-O)

    MDR report key: 11061221 · Received December 22, 2020

    Report

    Report Number
    3003152976-2020-00579
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 25, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WHICH DISPLAYS SEVERAL OPTIMA ADAPTERS WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTIONS, VARIATIONS OF COLOR BETWEEN THE MEMBRANES OF THE DIFFERENT ADAPTERS CAN BE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2002104, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR VISUAL INSPECTION. USING MAGNIFICATION, A SLIGHT VARIATION IN COLOR CAN BE OBSERVED ALTHOUGH IT IS NOT VISIBLE WITHOUT THE ENHANCED MAGNIFICATION. VISUAL INSPECTIONS OF THE PRODUCT, INCLUDING THE MEMBRANE, IS PERFORMED THROUGHOUT MANUFACTURING. COLOR VARIATIONS IN THE MEMBRANE IS EXPECTED BASED ON SEVERAL FACTORS INCLUDING, NO COLORANT IS ADDED TO RAW MATERIALS MAKING THE COLOR MORE PROMINENT, VARIATIONS IN RAW MATERIAL FROM BATCH TO BATCH, AND NORMAL CHANGES IN COLOR THAT CAN OVER THE MEMBRANE SHELF LIFE. BASED ON THE AVAILABLE INFORMATION , NO FAILURE IN THE MANUFACTURING PROCESS CAN BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PHASEAL¿ OPTIMA INFUSION ADAPTERS (C100-O) FROM LOT 2003101 AND 1 ADAPTER FROM LOT 2002104 WERE COMPARED AND FOUND TO HAVE "VARYING COLOURS OF RUBBER." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO C100-O ADAPTORS OF THE SAME LOT: 2003101 EXP FEB 28 2021 WHICH HAVE VARYING COLOURS OF RUBBER."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2003101, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2020-03-12. MEDICAL DEVICE LOT #: 2002104, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2020-03-10. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PHASEAL¿ OPTIMA INFUSION ADAPTERS (C100-O) FROM LOT 2003101 AND 1 ADAPTER FROM LOT 2002104 WERE COMPARED AND FOUND TO HAVE "VARYING COLOURS OF RUBBER". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO C100-O ADAPTORS OF THE SAME LOT: 2003101 EXP FEB 28 2021 WHICH HAVE VARYING COLOURS OF RUBBER"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524147 BD PHASEAL OPTIMA INFUSION ADAPTER (C100-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1