BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35

    MDR report key: 20180669 · Received September 10, 2024

    Report

    Report Number
    3003152976-2024-00503
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    September 6, 2024
    Report Date
    December 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905150036
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION: ONE INJECTOR SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE GRIPS OF THE SAFETY SLEEVE ARE OBSERVED TO BE BENT CAUSING THE NEEDLE TO BE EXPOSED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2404004, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. IT IS IMPORTANT TO GRIP THE WHITE INJECTOR COMPONENTS WHEN ENGAGING/ DISENGAGING; DO NOT GRIP THE BLUE SAFETY SLEEVE. IF THE SAFETY SLEEVE GRIPS BECOME DISLOCATED, THE INJECTOR IS ACTIVATED CAUSING NEEDLE EXPOSURE. TO PREVENT DAMAGE TO THE HANDLES OF THE SAFETY SLEEVE, THE INJECTOR MUST BE REMOVED BY PULLING IT BACKWARDS AND MUST NOT BE FORCEFULLY ENGAGED. THE INSTRUCTIONS FOR USE MUST BE CAREFULLY FOLLOWED WHEN USING PHASEAL DEVICES IN ORDER TO AVOID ANY DAMAGE TO THE PRODUCT THAT MAY RESULT IN THE DEVICE NOT FUNCTIONING AS INTENDED. BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. IT APPEARS THAT THIS INCIDENT WAS DUE TO EXCESSIVE FORCE DURING CONNECTION/DISCONNECTION OF THE DEVICE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED VIA EMAIL:PLEASE FIND ATTACHED A SECOND QUALITY DEFECT REPORT CONCERNING: BD PHASEAL INJECTOR LUER LOCK REF : 515003 LOT: 2404004 THE ENTIRE BATCH PRESUMED TO BE DEFECTIVE AS WELL AS THE INJECTOR CONCERNED BY THIS NEW INCIDENT ARE KEPT AT THE PUI, SINCE THIS IS THE SECOND INCIDENT REPORTED ON THIS BATCH, WOULD A REFUND OR EXCHANGE BE POSSIBLE? THE QUANTITY CONCERNED IS 8 INJECTORS. CIRCUMSTANCES / DESCRIPTION: AS SHE WITHDRAWS FROM THE PHASEAL SYSTEM PROTECTOR, THE STITCHER SEES THE INJECTOR CANULA STUCK IN THE SEPTUM. AFTER DISENGAGEMENT WITH DIFFICULTY, THE CANULA REMAINS OUTSIDE. CONSERVATION MEASURES AND ACTIONS TAKEN : THE INJECTOR WAS KEPT AT THE PUI MANUFACTURER AND INJECTOR DECLARATION AVAILABLE FOR ANALYSIS. WHOLE LOT KEPT (8 INJECTORS) REQUEST EXCHANGE OR REFUND.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331221 INJECTOR LUER LOCK N35 CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2404004 00382905150036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown