BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 16450248 · Received February 27, 2023

    Report

    Report Number
    3003152976-2023-00036
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY: ONE PHOTO WHICH HIGHLIGHTS THE AREA OF THE DEVICE WHERE THE ALLEGED LEAKAGE OCCURRED AND TWO UNUSED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE COMPONENTS OF THE INJECTORS. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. LIQUID COULD MOVE FROM THE VIAL TO THE SYRINGE AND BACK WITHOUT ISSUE AND NO LEAKAGES WERE OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. BASED ON THE SAMPLE INVESTIGATION AND OUR QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. DHR FROM INJECTOR N35 LOT 2111005 (ASSEMBLY LOTS 1302333 AND 1302332) WAS REVIEWED AND NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND THAT COULD BE RELATED TO THE EVENT REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF CHEMOTHERAPY FROM THE INJECTOR DURING THE DILUTION PHASE OF THE SUBSTANCE IN THE BAG THE INJECTOR WAS LEAKED CHEMO SUBSTANCE FROM THE MIDDLE OF THE DEVICE; THE CHEMOTHERAPY WAS CONTAMINATED THE OPERATOR, THE SURFACES AND ALL THE OBJECTS ON THE SURFACES; THE OPERATOR WEARING ALL THE REQUIRED DPI AND FOLLOWED THE EXPECTED SAFETY PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF CHEMOTHERAPY FROM THE INJECTOR DURING THE DILUTION PHASE OF THE SUBSTANCE IN THE BAG THE INJECTOR WAS LEAKED CHEMO SUBSTANCE FROM THE MIDDLE OF THE DEVICE; THE CHEMOTHERAPY WAS CONTAMINATED THE OPERATOR, THE SURFACES AND ALL THE OBJECTS ON THE SURFACES; THE OPERATOR WEARING ALL THE REQUIRED DPI AND FOLLOWED THE EXPECTED SAFETY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786793 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515003 2111005 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown