BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN, 1 ML

    MDR report key: 16519368 · Received March 9, 2023

    Report

    Report Number
    1213809-2023-00168
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    January 9, 2023
    Report Date
    July 19, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE BARREL IS MISSING MOST OF ITS SCALE MARKINGS. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2172095 AND 2131738. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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

    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 WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN, 1 ML THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT STATED THAT 1 DOSING SYRINGE DID NOT HAVE NUMBERS TO MEASURE VOLUME ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292691 BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN, 1 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 2172095 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown