BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    MDR report key: 11846153 · Received May 18, 2021

    Report

    Report Number
    3003152976-2021-00270
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. ONE PHOTO OF A N35-O INJECTOR, WHICH IS DIFFERENT THAN THE INJECTOR REPORTED, CONNECTED TO A SPIROS PRODUCT AND SYRINGE WAS PROVIDED. THERE WAS NO EVIDENCE OF A LEAK OBSERVED WITHIN THE PHOTO. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012310, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FOUR RETAINED SAMPLES OF LOT 2012310 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO LEAKAGES OCCURRED. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA INJECTOR (N40-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515056 BATCH NO.: 2012310. THE PHARMACY TECH WAS COMPOUNDING A HD AND THE VIAL HAD A SPIROS TOP ON THE VIAL. SHE WAS DIRECTED TO USE SPIROS PIECES TO DRAW THE DRUG OUT THEN LUER LOCK AN INJECTOR ON THE END OF THE SPIROS PIECE. WHEN CONNECTING THE INJECTOR TO THE CONNECTOR ON THE INFUSION ADAPTER THERE WAS LEAKAGE WHEN SHE INFUSED THE DRUG INTO THE BAG.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA INJECTOR (N40-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515056 BATCH NO.: 2012310. THE PHARMACY TECH WAS COMPOUNDING A HD AND THE VIAL HAD A SPIROS TOP ON THE VIAL. SHE WAS DIRECTED TO USE SPIROS PIECES TO DRAW THE DRUG OUT THEN LUER LOCK AN INJECTOR ON THE END OF THE SPIROS PIECE. WHEN CONNECTING THE INJECTOR TO THE CONNECTOR ON THE INFUSION ADAPTER THERE WAS LEAKAGE WHEN SHE INFUSED THE DRUG INTO THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742086 BD PHASEAL OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 2012310 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1