BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 17027032 · Received May 30, 2023

    Report

    Report Number
    1920898-2023-00320
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H6: INVESTIGATION SUMMARY: NO SAMPLES 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# 2213872. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, THE NEEDLE HUB SEPARATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLE SHIELD DIFFICULT TO REMOVE. NEEDLE BENT WHILE TRYING TO REMOVE THE SHIELD. ALSO REPORTED NEEDLE HUB SEPARATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089699 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 2213872 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown