BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20693687 · Received November 15, 2024

    Report

    Report Number
    1911916-2024-00814
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE ARE INCOMPLETE AND MISSING GRADUATION MARKS. TO AID IN THE INVESTIGATION, TWENTY-THREE SAMPLES IN SEALED PACKAGING BLISTERS AND FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES RECEIVED ARE MISSING THE SYRINGE SCALE MARKING, AND THE FIVE PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. NO OTHER DEFECTS AND IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM INDUCING A MISALIGNMENT OF THE PRINTING PAD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080219. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 309650. BATCH NUMBER#: 4080219. IT WAS REPORTED BY CUSTOMER THAT THEY RECEIVED 50ML LUER-LOK SYRINGES WHICH DEMONSTRATE POOR QUALITY CONTROL DURING MANUFACTURE. NUMEROUS SYRINGES CAME FROM THE MANUFACTURER WITH INCOMPLETE GRADUATION MARKS, OR ENTIRELY WITHOUT GRADUATION MARKS. NO PATIENT HARM, MANUFACTURING DEFECT PRECLUDES PRODUCT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187707 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown