BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16064627 · Received December 28, 2022

    Report

    Report Number
    1920898-2022-00906
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 9, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. 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 OR 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# 1173312. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BROKE OFF WHEN REMOVING IT FROM THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BREAKS WHEN REMOVING FROM THE INJECTION SITE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BROKE OFF WHEN REMOVING IT FROM THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BREAKS WHEN REMOVING FROM THE INJECTION SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106148 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1173312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown