BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5 ML S/T BNS

    MDR report key: 16301865 · Received February 4, 2023

    Report

    Report Number
    1213809-2023-00059
    Event Type
    Malfunction
    Date Received
    February 4, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL, YES. D10: RETURNED TO MANUFACTURER ON: 14-FEB-2023. TEN SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND TEN LOOSE SAMPLES HAVE LIGHT AND MISSING PRINT OF THE SCALE MARKINGS. THE IMAGE SHOWS SIX LOOSE SYRINGES SHOWING THE NUMBERS AND THE ML AREA OF THE BARREL WITH THE "M" BLURRY ON ALL THE SYRINGES AND THE "L" MISSING ON FOUR SYRINGES. POTENTIAL ROOT CAUSE FOR THE MISSING AND SMEARED PRINT DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2160605. A REVIEW SHOWED ONE NOTIFICATION DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 327 BD SYRINGE 5 ML S/T BNS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MANUFACTURING REPORTED TO FIND 327 PARTS OF MATERIAL K-05600-025A BATCH 13P22K0646 WITH A SMEARED PRINTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 327 BD SYRINGE 5 ML S/T BNS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MANUFACTURING REPORTED TO FIND 327 PARTS OF MATERIAL K-05600-025A BATCH 13P22K0646 WITH A SMEARED PRINTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81277 BD SYRINGE 5 ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2160605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown