BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20383365 · Received October 7, 2024

    Report

    Report Number
    1911916-2024-00716
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE SYRINGE DID NOT HAVE MARKINGS ON IT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL IS MISSING THE SCALE MARKING. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM MISALIGNING THE PRINTING PAD DURING THE SYRINGE BARREL PRINTING PROCESS. 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 SAMPLE 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. MATERIAL # 309653; BATCH # 4080219. IT WAS REPORTED BY CUSTOMER THAT THE 50ML SYRINGE NOT HAVING MARKINGS ON IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CHILDREN'S MINNESOTA HAS AGAIN EXPERIENCED ISSUES WITH THE 50ML SYRINGE NOT HAVING MARKINGS ON IT. PLEASE SEE PRODUCT INFO BELOW AND PHOTO ATTACHED. I DO HAVE THE PRODUCT SAMPLE IF NEEDED FOR INVESTIGATION. BD 50 ML LUER LOK SYRINGE: MFG # 309653. LOT # 4080219.

    Description of Event or Problem · 0

    MATERIAL # 309653, BATCH # 4080219. IT WAS REPORTED BY CUSTOMER THAT THE 50ML SYRINGE NOT HAVING MARKINGS ON IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(6) HAS AGAIN EXPERIENCED ISSUES WITH THE 50ML SYRINGE NOT HAVING MARKINGS ON IT. PLEASE SEE PRODUCT INFO BELOW AND PHOTO ATTACHED. I DO HAVE THE PRODUCT SAMPLE IF NEEDED FOR INVESTIGATION. BD 50 ML LUER LOK SYRINGE. MFG # 309653. LOT # 4080219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541797 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080219 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown