BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9876108 · Received March 24, 2020

    Report

    Report Number
    1920898-2020-00299
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8162506. CUSTOMER STATES THAT THERE IS SOMETHING OF ORANGE COLOR IN THE BARREL. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A PIECE OF ORANGE MATERIAL CAUGHT IN BETWEEN THE HUB AND BARREL TIP. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYETHYLENE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8162506. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200766128, 200766168] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1/2CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS.REVIEWED L2L DISPATCHED, IDENTIFIED A DISPATCH FOR ISSUES WITH NEEDLE THROUGH SHIELD EJECT AND CLEANED THE EJECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE HAD FOREIGN MATTER ON DEVICE CANNULA / IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:" THERE IS SOMETHING OF ORANGE COLOR IN THE BARREL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE HAD FOREIGN MATTER ON DEVICE CANNULA / IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:" THERE IS SOMETHING OF ORANGE COLOR IN THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339608 BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 324911 8162506 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other