BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR (N40-O)

    MDR report key: 15946704 · Received December 8, 2022

    Report

    Report Number
    3003152976-2022-00547
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 3, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150563
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT# 22033032 WAS NOT FOUND FOR THE REPORTED CATALOG# NS515056. 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 THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. SUSPECTED LOT 22033032 IS NOT A VALID LOT CODE FOR THE REPORTED MATERIAL, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AND ADDITIONAL RETAINED SAMPLE COULD NOT BE EVALUATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOT 2206301, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE 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 THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE SYRINGE AND LEAKED CHEMOTHERAPY MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE MIXING CHEMO TODAY I TRIED TO REMOVE THE INJECTOR FROM THE PROTECTOR ON THE VIAL AFTER A DOSE WAS DRAWN UP. THE INJECTOR SHOULD HAVE STAYED ATTACHED TO THE SYRINGE HOWEVER IT STAYED ON THE VIAL, SO THE SYRINGE WAS UNCAPPED AND CAUSING DRIPS TO SPLASH ON THE DECK IN THE HOOD... WE DID EXPERIENCE A CHEMO SPILL ON EACH OF THESE OCCASIONS. IT WAS CLEANED UP APPROPRIATELY AND WE CONTINUED WITH COMPOUNDING. THE ADVERSE EVENTS WERE JUST RISK OF EXPOSURE AND DELAY IN DISPENSING CHEMO."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE SYRINGE AND LEAKED CHEMOTHERAPY MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE MIXING CHEMO TODAY I TRIED TO REMOVE THE INJECTOR FROM THE PROTECTOR ON THE VIAL AFTER A DOSE WAS DRAWN UP. THE INJECTOR SHOULD HAVE STAYED ATTACHED TO THE SYRINGE HOWEVER IT STAYED ON THE VIAL, SO THE SYRINGE WAS UNCAPPED AND CAUSING DRIPS TO SPLASH ON THE DECK IN THE HOOD... WE DID EXPERIENCE A CHEMO SPILL ON EACH OF THESE OCCASIONS. IT WAS CLEANED UP APPROPRIATELY AND WE CONTINUED WITH COMPOUNDING. THE ADVERSE EVENTS WERE JUST RISK OF EXPOSURE AND DELAY IN DISPENSING CHEMO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597622 BD PHASEAL¿ OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 2206301 30382905150563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown