BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL

    MDR report key: 12468168 · Received September 14, 2021

    Report

    Report Number
    1213809-2021-00635
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. MARKING AND ASSEMBLY DEVICE HISTORY RECORD WERE CHECKED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. MARKER ISSUES WERE RECORDED DURING ONE OF THE SUB-ASSEMBLY BATCHES. BATCH 9003923 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE MARKINGS ON THE SYRINGE WERE LOWER THAN THE MARKINGS ON A NORMAL SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363946 SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9003923 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1