BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 16091651 · Received January 3, 2023

    Report

    Report Number
    3003152976-2022-00594
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 13, 2022
    Report Date
    February 13, 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
    PHYSICIAN
    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

    H6: INVESTIGATION SUMMARY: SEVERAL PHOTOS OF THE IMPACTED DEVICE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE ROTATIONS STOPS WERE BROKEN AND THE GRIPS OF THE SAFETY SLEEVE ARE DAMAGED AND MOVED FROM THEIR PROPER POSITION CAUSING THE NEEDLE TO BE EXPOSED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111005, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. 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 DISCONNECTION OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 THERE WAS BREAKAGE AND NEEDLE EXPOSURE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE DISCONNECTION PHASE, THE INJECTOR BROKE, EXPOSING THE INTERNAL NEEDLE. WHILE DISCONNECTING THE INJECTOR FROM THE PROTECTOR, THE INTERNAL NEEDLE WAS UNCOVERED AND DID NOT GO BACK INTO ITS SEAT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 THERE WAS BREAKAGE AND NEEDLE EXPOSURE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE DISCONNECTION PHASE, THE INJECTOR BROKE, EXPOSING THE INTERNAL NEEDLE. WHILE DISCONNECTING THE INJECTOR FROM THE PROTECTOR, THE INTERNAL NEEDLE WAS UNCOVERED AND DID NOT GO BACK INTO ITS SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146216 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