BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9505054 · Received December 20, 2019

    Report

    Report Number
    1920898-2019-01457
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 5, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140733. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE "HARD TO READ" DURING USE FOR THE "VISUALLY IMPAIRED" CONSUMER, WHO HAD TO USE A MAGNIFYING GLASS. ADDITIONALLY, IT WAS REPORTED THAT THE SYRINGE BARREL WAS "LONGER" AND THE NEEDLE WAS "SHORTER" THAN OTHER SYRINGES USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED SHE BROUGHT THE SYRINGE BOX THAT WAS ADVERTISED, WHEN SHE WAS USING IT, SCALE MARK WAS HARD TO READ, SHE IS VISUALLY IMPAIRED SHE HAD TO USE THE MAGNIFYING GLASS. CONSUMER STATED IN THIS ITEM, THE BARREL IS LONGER AND NEEDLE IS SHORTER THAN THE ONES SHE USES. CONSUMER USES 328440 SYRINGES. 8MM, 3/10 ML. 30ML."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE "HARD TO READ" DURING USE FOR THE "VISUALLY IMPAIRED" CONSUMER, WHO HAD TO USE A MAGNIFYING GLASS. ADDITIONALLY, IT WAS REPORTED THAT THE SYRINGE BARREL WAS "LONGER" AND THE NEEDLE WAS "SHORTER" THAN OTHER SYRINGES USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED SHE BROUGHT THE SYRINGE BOX THAT WAS ADVERTISED, WHEN SHE WAS USING IT, SCALE MARK WAS HARD TO READ, SHE IS VISUALLY IMPAIRED SHE HAD TO USE THE MAGNIFYING GLASS. CONSUMER STATED IN THIS ITEM, THE BARREL IS LONGER AND NEEDLE IS SHORTER THAN THE ONES SHE USES. CONSUMER USES 328440 SYRINGES. 8MM, 3/10 ML. 30ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302501 BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324912 9140733 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other