BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 15225528 · Received August 15, 2022

    Report

    Report Number
    3002682307-2022-00212
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2112311 . MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. DEVICE MANUFACTURE DATE: 04-JAN-2022. MEDICAL DEVICE LOT #: 2112305. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. DEVICE MANUFACTURE DATE: 20-DEC 2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES OR PICTURES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2112311 AND 2112305, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOTS 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 LOTS 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 THAT 2 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED A BROKEN LUER CONNECTION WHICH RESULTED IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER LOCK COMING DISCONNECT FROM THE END OF THE LINE. DRUG WAS SPILLED NO PATIENT IMPACT OR ADVERSE EVENT TO THE PATIENT, BUT A NURSE WAS EXPOSED TO CHEMO. GEMCITABINE LEAKED ONTO HER HAND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PHASEAL OPTIMA INJECTORS (N35-O) EXPERIENCED A BROKEN LUER CONNECTION WHICH RESULTED IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER LOCK COMING DISCONNECT FROM THE END OF THE LINE. DRUG WAS SPILLED NO PATIENT IMPACT OR ADVERSE EVENT TO THE PATIENT, BUT A NURSE WAS EXPOSED TO CHEMO. GEMCITABINE LEAKED ONTO HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295265 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE H10 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown