BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11155917 · Received January 12, 2021

    Report

    Report Number
    1920898-2021-00032
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    December 15, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    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# 0203537. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200902242] NOTED FOR DAMAGED TIPS CAUSING MISSING PRINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCALE MARKINGS WERE MISSING WITH A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NO MARKINGS ON INSULIN SYRINGE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, HOWEVER, (B)(6) WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCALE MARKINGS WERE MISSING WITH A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NO MARKINGS ON INSULIN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51765 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0203537

    Patients

    Seq Age Sex Outcome Treatment
    1