BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 17239482 · Received June 30, 2023

    Report

    Report Number
    1920898-2023-00418
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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

    H6: INVESTIGATION SUMMARY: 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# 2213846. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN HE DRAWS HIS INSULIN, IT IS HARD TO PUSH ON THE PLUNGER ROD TO TAKE INJECTION STATED, THERE ARE TIME WHEN HE CANNOT DRAW HIS INSULIN BECAUSE THE PLUNGER ROD IS HARD TO MOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN HE DRAWS HIS INSULIN, IT IS HARD TO PUSH ON THE PLUNGER ROD TO TAKE INJECTION STATED, THERE ARE TIME WHEN HE CANNOT DRAW HIS INSULIN BECAUSE THE PLUNGER ROD IS HARD TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484861 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328290 2213846 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown