BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T BNS

    MDR report key: 15245234 · Received August 17, 2022

    Report

    Report Number
    1213809-2022-00507
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN D.4. MEDICAL DEVICE LOT #: 1061961 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-JAN-2026 H.4. DEVICE MANUFACTURE DATE: 03-MAR-2021 H.6. INVESTIGATION SUMMARY: ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SYRINGE WAS MISSING MOST OF ITS PRINTED SCALE MARKS. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. THESE DEFECTS ARE OCCURRING AT AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1061961. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. AS THE OTHER BATCH 163249 INVOLVED IN THIS INCIDENT IS INVALID, A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1 ML S/T BNS SCALE MARKING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES WITH NO PRINT ON IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1 ML S/T BNS SCALE MARKING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES WITH NO PRINT ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297193 BD SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown