BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.5 ML BD INSULIN SYRINGE WITH 29 G X 6 MM BD ULTRA-FINE¿ NEEDLE

    MDR report key: 6969430 · Received October 23, 2017

    Report

    Report Number
    1920898-2017-00273
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 29, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO SAMPLES OR PHOTOS ARE AVAILABLE FOR REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 4121917. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED DURING PRODUCTION OF THE ABOVE LISTED BATCH(ES), AS NOTED THROUGH DEVICE HISTORY RECORD REVIEW. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON A 0.5 ML BD INSULIN SYRINGE WITH 29 G X 6 MM BD ULTRA-FINE¿ NEEDLE WAS DIFFICULT TO MOVE AND THE PATIENT FELT RESISTANCE WHILE INJECTING MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747386 0.5 ML BD INSULIN SYRINGE WITH 29 G X 6 MM BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 4121917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other