BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35C MULTIPACK

    MDR report key: 11307260 · Received February 10, 2021

    Report

    Report Number
    3003152976-2021-00071
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150050
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE INJECTOR SAMPLE OF LOT 2003102 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE WAS IDENTIFIED ON THE INJECTOR CANNULA, SAFETY SLEEVE, INJECTOR PISTONS, OR THE LUER OF THE INJECTOR. FUNCTIONAL EVALUATIONS WERE CONDUCTED, FILLING A SYRINGE WITH AIR AND CONNECTING TO THE INJECTOR, THE UNIT WAS THEN ATTACHED TO A SAMPLE PROTECTOR AND VIAL. LIQUID WAS PROPERLY ASPIRATED FROM THE VIAL AND COULD MOVE TO THE SYRINGE AND BACK WITHOUT ISSUE, NO LEAKAGES WERE OBSERVED AND THERE WAS NO ISSUES RELATED TO THE LUER CONNECTION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003102, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED ON ANY OF THE INJECTORS. ALL SAMPLES WERE PROPERLY CONNECTED TO A SYRINGE, PROTECTOR, AND VIAL. AGAIN, LIQUID WAS PROPERLY ASPIRATED AND COULD MOVE BETWEEN THE VIAL AND SYRINGE WITHOUT ISSUES, NO LEAKAGE OR LUER BREAKAGE OCCURRED. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT MANUFACTURING, INCLUDING VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING WAS REVIEWED FOR LOT 2003102 AND NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35C MULTIPACK BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515005 BATCH, NO.: 2003102. IT WAS REPORTED THAT WHILE DRAWING UP MEDICATION AND TAPPING ON THE SYRINGE TO BRING AIR BUBBLES TO THE TOP, THE LEUR LOCK PIECE OF THE INJECTOR BROKE OFF CAUSING THE VIAL TO FLY ACROSS THE HOOD CAUSING A CHEMO SPILL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35C MULTIPACK BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515005, BATCH NO.: 2003102. IT WAS REPORTED THAT WHILE DRAWING UP MEDICATION AND TAPPING ON THE SYRINGE TO BRING AIR BUBBLES TO THE TOP, THE LEUR LOCK PIECE OF THE INJECTOR BROKE OFF CAUSING THE VIAL TO FLY ACROSS THE HOOD CAUSING A CHEMO SPILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205537 INJECTOR LUER LOCK N35C MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2003102 00382905150050

    Patients

    Seq Age Sex Outcome Treatment
    1