BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SYRINGES

    MDR report key: 7927495 · Received October 2, 2018

    Report

    Report Number
    1920898-2018-00752
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1CC, 6MM SYRINGE. CUSTOMER STATES THAT THERE WAS A CLEAR LIQUID INSIDE THE BARREL OF THE SYRINGE. THE RETURNED SYRINGE WAS TESTED AND A SMALL DROPLET OF CLOUDY MATERIAL CAME OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE BARREL AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY INSULIN. THIS MATERIAL WOULD MOST LIKELY NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8022941. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE, HOWEVER, THIS MATERIAL WOULD MOST LIKELY NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ SYRINGES THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768372 BD ULTRA-FINE¿ SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8022941 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other