BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 17365855 · Received July 20, 2023

    Report

    Report Number
    2243072-2023-01279
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A SCALE PRINTING ERROR. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH THE SCALE MARKING SKEWED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. AS NO MATERIAL OR LOT NUMBER WAS PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. VERIFICATION OF THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS AND ALIGNMENT OF THE FEEDER WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED BD SYRINGE THERE WAS ISSUES WITH THE SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADVISED BY A HEALTHCARE PROVIDER OF A PRINTING ERROR ON A SYRINGE AT XXX MN (B)(6) 2023. SYRINGE HAS DISCARDED AND NOT USED FOR PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED BD SYRINGE THERE WAS ISSUES WITH THE SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADVISED BY A HEALTHCARE PROVIDER OF A PRINTING ERROR ON A SYRINGE AT XXX MN (B)(6) 2023. SYRINGE HAS DISCARDED AND NOT USED FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883898 UNSPECIFIED BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown