BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 7026684 · Received November 13, 2017

    Report

    Report Number
    2243072-2017-00224
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - CUSTOMER RETURNED (4) LOOSE 3/10CC, 8MM SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED NEARLY ALL OF THE MARKINGS MISSING FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION - POSSIBLE ROOT CAUSES FOR MISSING SCALE MARKINGS INCLUDE: DAMAGE TO THE PAD, PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER, PAD HEAT SET INCORRECTLY, PRINT HEAD TIMING OUT OF ADJUSTMENT, PAD INDICATION SET INCORRECTLY, PLUGGED INK NOZZLE, INK PUMP FAULT, INK NOZZLE SET INCORRECTLY, BRASS ROLLER SET INCORRECTLY, WORN PRINT HEAD BEARINGS CAPA 162566 WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD SYRINGE PRODUCT WAS MISSING THE PRINTED SCALE MARKINGS. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803039 UNSPECIFIED BD SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other