BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O

    MDR report key: 17603970 · Received August 23, 2023

    Report

    Report Number
    3003152976-2023-00345
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150784
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOT 2210504, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THREE RETAINED SAMPLES OF THE SUSPECTED 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 LEAKAGE TESTING. NO ISSUES RELATED TO LEAKAGE WERE FOUND DURING THESE INSPECTIONS. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. THE REPORTED LOT# [2210504]WAS NOT FOUND FOR THE REPORTED CATALOG# [515078]. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H3. 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¿ OPTIMA INFUSION ADAPTER C100-O WAS LEAKING. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CALLER STATES THE LEAKING OCCURRED ABOUT A MONTH AGO AND IS SECONDHAND INFORMATION FROM THE NURSES, SO HE IS UNSURE WHERE THE LEAKING OCCURRED FROM EXACTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O WAS LEAKING. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CALLER STATES THE LEAKING OCCURRED ABOUT A MONTH AGO AND IS SECONDHAND INFORMATION FROM THE NURSES, SO HE IS UNSURE WHERE THE LEAKING OCCURRED FROM EXACTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264852 BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905150784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown