BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    MDR report key: 15763836 · Received November 9, 2022

    Report

    Report Number
    3003152976-2022-00502
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 14, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201305, 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 ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. DIMENSIONAL TESTING WAS PERFORMED, INCLUDING THE LUER THREAD, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS. RECORDS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES RELATED TO THIS FAILURE WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O THE INJECTOR BROKE DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: N-35 INJECTOR BROKE OFF WHEN ATTACHED TO A SYRINGE. TECHNICIAN WAS ATTEMPTING TO ACCESS A VIAL FOR RECONSTITUTION AND IT SNAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O THE INJECTOR BROKE DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: N-35 INJECTOR BROKE OFF WHEN ATTACHED TO A SYRINGE. TECHNICIAN WAS ATTEMPTING TO ACCESS A VIAL FOR RECONSTITUTION AND IT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463489 BD PHASEAL¿ OPTIMA INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201305 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown