BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE 0.3ML, 31G X 8MM

    MDR report key: 6570519 · Received May 16, 2017

    Report

    Report Number
    1920898-2017-00060
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 25, 2017
    Report Date
    May 16, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6242643. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER SUFFERED A NEEDLE STICK BEFORE USE AS HE WAS REMOVING THE CAP FROM A BD INSULIN SYRINGE 0.3ML, 31G X 8MM. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352311 BD INSULIN SYRINGE 0.3ML, 31G X 8MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other