BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE

    MDR report key: 11949844 · Received June 7, 2021

    Report

    Report Number
    1920898-2021-00641
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294610
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 6/9/2021. H6: INVESTIGATION: CUSTOMER RETURNED (5) LOOSE 1/2CC, 12.7MM SYRINGES. CUSTOMER STATES THAT THE SYRINGES HAVE AN UNIDENTIFIED LIQUID IN THE SYRINGE. ALL RETURNED SYRINGES WERE TESTED AND ALL EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. 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# 0132264. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR EXCESSIVE SILICONE. CORRECTIVE ACTION: REPLACED SILICONE GUN #7. VISUALLY INSPECTED 100 PARTS FINDING 0 DEFECTS PRIOR TO MACHINE START UP. THE AFFECTED PRODUCT WAS SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BOXES OF BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD FOREIGN LIQUID FOUND INSIDE THE SYRINGE BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE END USER HAS STARTED USING THE SYRINGES AND NOTED THAT APPROXIMATELY 40% OF THE SYRINGES HAVE AN UNIDENTIFIED LIQUID IN THE SYRINGE. ALL FIVE BOXES HAVE THIS ISSUE."

    Additional Manufacturer Narrative · 1

    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 THAT 5 BOXES OF BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD FOREIGN LIQUID FOUND INSIDE THE SYRINGE BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE END USER HAS STARTED USING THE SYRINGES AND NOTED THAT APPROXIMATELY 40% OF THE SYRINGES HAVE AN UNIDENTIFIED LIQUID IN THE SYRINGE. ALL FIVE BOXES HAVE THIS ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843889 BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329461 0132264 30382903294610

    Patients

    Seq Age Sex Outcome Treatment
    1