BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA

    MDR report key: 18166436 · Received November 17, 2023

    Report

    Report Number
    1213809-2023-01284
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 21, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4): FOLLOW UP MDR FOR DEVICE EVALUATION. TWO PHOTOS WERE PROVIDED. THEY SHOW A NEEDLE ASSEMBLY INJECTED INTO A HUMAN BODY. IT IS DISASSEMBLED FROM THE SYRINGE. IT IS NOT SHOWN THAT THE NEEDLE WAS PULLED OUT OF THE NEEDLE HUB; WHAT IT SHOWS IS THE NEEDLE ASSEMBLY DISASSEMBLED FROM THE SYRINGE. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTOS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1152520 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTEGRA SYRINGE NEEDLE WAS PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAME APART DURING NORMAL USE". "I USE YOUR SYRINGES WITH AN EXPENSIVE ANTIOXIDANT /B-12 COMPLEX AND HAVE HAD MULTIPLE ISSUES WITH THIS PARTICULAR BATCH OF SYRINGES. I TOOK A PHOTO THIS LAST TIME-IT IS CAUSING UNNECESSARY ADDITIONAL INJECTIONS AND WASTING MY 'MEDICINE'. I WOULD LIKE TO BE COMPENSATED IN SOME WAY FOR THE LOSS. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673384 BD INTEGRA PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 1152520 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown