BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10388910 · Received August 10, 2020

    Report

    Report Number
    1920898-2020-01018
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (24) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THERE IS LIQUID IN THE BARREL. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED IN ANY OF THE SAMPLES. HOWEVER, WHEN THE PLUNGER ROD WAS FULLY DEPRESSED, A SMALL, CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA OF 11 OUT OF 24 SAMPLES. 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 SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9014703. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200805562] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200805534] NOTED FOR SILICONE OUTER DIAMETER OF BARREL. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, 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. ROOT CAUSE: QN (B)(4) WAS CREATED FOR SILICONE ON OD OF BARREL. L2L DISPATCH 57898 WAS CREATED FOR THE SILICONE GUNS. THE SILICONE GUNS WERE STUCK IN PURGE MODE, SO THEY WERE FIRING CONSTANTLY. CORRECTION: TURNED THE PURGE MODE OFF, CLEANED PREP DIAL AND RAILS. CREATED QN (B)(4) H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID WAS FOUND IN THE BARRELS OF 5 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID IN BARREL ABOUT 0.1~0.2 UNIT."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID WAS FOUND IN THE BARRELS OF 5 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID IN BARREL ABOUT 0.1~0.2 UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853382 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9014703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other