BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19825753 · Received July 25, 2024

    Report

    Report Number
    1911916-2024-00540
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 14, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 THE VOLUME MARKINGS ON SIDE OF SYRINGE ARE MISSING HALFWAY UP THE SYRINGE. TO AID IN THE INVESTIGATION, TWENTY SAMPLES AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTEEN OF THE SAMPLES CAME IN SEALED PACKAGING BLISTERS, ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER AND ONE SAMPLE CAME WITH NO PACKAGING. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL SCALE IS PARTIALLY PRINTED. THE PHOTO PROVIDED SHOWS A SYRINGE WITH A PARTIALLY PRINTED SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080174. 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 ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL: 309653, BATCH#: 4080174. IT WAS REPORTED BY THE CUSTOMER THAT VOLUME MARKINGS ON SIDE OF SYRINGE IS MISSING HALFWAY UP THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. VOLUME MARKINGS ON SIDE OF SYRINGE IS MISSING HALFWAY UP THE SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 309653, BATCH#: 4080174. IT WAS REPORTED BY THE CUSTOMER THAT VOLUME MARKINGS ON SIDE OF SYRINGE IS MISSING HALFWAY UP THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. VOLUME MARKINGS ON SIDE OF SYRINGE IS MISSING HALFWAY UP THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365298 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown