BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    MDR report key: 8020338 · Received October 30, 2018

    Report

    Report Number
    3003152976-2018-00465
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE INJECTOR SAMPLE UNIT BELONGING TO LOT NUMBER 1803108 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. A DEVICE HISTORY RECORD REVIEW FOR LOT NUMBER 1803108 DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLES, THE LUER CONNECTION COMPONENT OF THE INJECTOR PRODUCT WAS FOUND BROKEN AND REMAINED ATTACHED TO THE SYRINGE. AS THE SEPARATED LUER COMPONENT WAS PROPERLY ATTACHED TO THE SYRINGE, IT IS SUGGESTED THAT THE LUER THREADS WERE NOT DEFECTIVE. NO ISSUES WERE FOUND WITH THE RETURNED PROTECTOR. IT HAS BEEN DETERMINED THAT THE BREAKAGE LIKELY OCCURRED AS A RESULT OF INCORRECT HANDLING BY THE USER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861501 BD PHASEAL¿ INJECTOR LUER LOCK N35J CLOSED SYSTEM DRUG DELIVERY LHI BECTON DICKINSON, S.A. 1803108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other