BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BRAZIL

    MDR report key: 20771051 · Received November 25, 2024

    Report

    Report Number
    3003152976-2024-00611
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 14, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903035526
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE WAS A DIVERGENCE OF THE GRADUATION AROUND 2ML. TO AID IN THE INVESTIGATION, FOUR SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO SAMPLES CAME IN SEALED PACKAGING BLISTERS AND TWO SAMPLES CAME WITH NO PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED. TWO SAMPLES HAVE NO DEFECTS OR IMPERFECTIONS, AND THE OTHER TWO SAMPLES HAVE THE SYRINGE BARREL SCALE MARKING ZERO-LINE 3/32" SHIFTED UP. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM AT THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT 4122736. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    DIVERGENCE OF GRADUATION AROUND 2 ML. THIS SYRINGE IS WIDELY USED IN ONCOLOGY PHARMACIES WHERE THE VARIATION IS QUITE SIGNIFICANT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED WAS THERE ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828882 SYRINGE 50ML LL BRAZIL SYRINGE, PISTON FMF BECTON DICKINSON 4122736 00382903035526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown