BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N40-O

    MDR report key: 14761118 · Received June 21, 2022

    Report

    Report Number
    3003152976-2022-00285
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH INITIAL INSPECTIONS, THERE WAS NO VISIBLE DAMAGE TO THE INJECTOR, HOWEVER, A LEAKAGE WAS OBSERVED, VERIFYING THE REPORTED INCIDENT. THE PRODUCT WAS DISASSEMBLED FOR FURTHER EVALUATION, IT WAS FOUND THE NEEDLE HOUSING WAS BROKEN AND THERE WAS NO CANNULA INSIDE AS IT HAD LIKELY FALLEN OUT DURING THE MANUFACTURING PROCESS. A CAMERA SYSTEM USED TO VERIFY THE PROPER ASSEMBLY OF THE CANNULA AND CHECK THE CANNULA TIP, DISCARDING ANY PRODUCT THAT DOES NOT HAVE THE CANNULA PROPERLY ASSEMBLED. THIS SYSTEM IS CHALLENGED ACCORDING TO PROCEDURE TO ENSURE IT PROPERLY IDENTIFIES AND DISCARDS DEFECTIVE PRODUCT. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, THEREFORE WE CANNOT ESTABLISH A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE THROUGH THE PHASEAL CONNECTION WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N40-O. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LEAK RELATED TO A PHASEAL N40-O IN MAYS ATC PHARMACY AND THE NURSE CONFIRMED THE LUER LOCK WAS ON TIGHT WHEN BEVACIZUMAB CONTINUED TO LEAK THROUGH THE PHASEAL CONNECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE THROUGH THE PHASEAL CONNECTION WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N40-O. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LEAK RELATED TO A PHASEAL N40-O IN MAYS ATC PHARMACY AND THE NURSE CONFIRMED THE LUER LOCK WAS ON TIGHT WHEN BEVACIZUMAB CONTINUED TO LEAK THROUGH THE PHASEAL CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895202 BD PHASEAL¿ OPTIMA INJECTOR N40-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 UNKNOWN 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown