BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8670260 · Received June 5, 2019

    Report

    Report Number
    1920898-2019-00512
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 5131785. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR DAMAGED BARREL. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 328466 BATCH NO. 5131785. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE FLANGES SEEM SHORTER AND HARDER TO HOLD, PLUNGER ROD HARD TO MOVE DURING INJECTION, AND NEEDLE SHIELDS ARE HARD TO REMOVE. THERE WERE THREE UNITS IN THE LOT THAT WERE IN QUESTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 328466 LOT # 5131785 WITH 3 SUBJECTS FLANGES SEEM SHORTER AND HARDER TO HOLD. PLUNGER STOPPER HARD TO MOVE DURING INJECTION. ORANGE NEEDLE SHIELDS HARD TO REMOVE

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 328466 BATCH NO. 5131785. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE FLANGES SEEM SHORTER AND HARDER TO HOLD, PLUNGER ROD HARD TO MOVE DURING INJECTION, AND NEEDLE SHIELDS ARE HARD TO REMOVE. THERE WERE THREE UNITS IN THE LOT THAT WERE IN QUESTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 328466 LOT # 5131785 WITH 3 SUBJECTS. FLANGES SEEM SHORTER AND HARDER TO HOLD. PLUNGER STOPPER HARD TO MOVE DURING INJECTION. ORANGE NEEDLE SHIELDS HARD TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464238 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 5131785 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other