BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11417818 · Received March 4, 2021

    Report

    Report Number
    1920898-2021-00266
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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: 2021-03-18. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) 3/10CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 0160001. CUSTOMER STATES THAT ONE SYRINGE WHEN PRESSING THE PLUNGER, A LIQUID CAME OUT OF THE NEEDLE. ALL RETURNED SYRINGES WERE TESTED AND ALL EXHIBITED A SMALL CLEAR DROPLET OF MATERIAL COMING OUT OF THE CANNULA 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# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) #(B)(4) WAS CREATED ON 16OCT2020 FOR EXCESSIVE SILICON BEING PUT IN THE BARRELS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA/IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512, BATCH NO: 0160001. CONSUMER REPORTED FINDING A LIQUID COMING OUT OF NEEDLE WHEN PRESSING THE PLUNGER.

    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 THE RELION® INSULIN SYRINGE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA/IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512 BATCH NO: 0160001. CONSUMER REPORTED FINDING A LIQUID COMING OUT OF NEEDLE WHEN PRESSING THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314150 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1