BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE 3/10ML 29G X 8MM

    MDR report key: 16412270 · Received February 21, 2023

    Report

    Report Number
    1920898-2023-00060
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 26, 2023
    Report Date
    June 9, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    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: 24-FEB-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (4) SYRINGE 0.3ML 31GA 8MM IN AN OPEN POLY BAG FROM LOT# 2213837. IT WAS REPORTED BY THE CONSUMER THAT LIQUID COMES OUT FROM SYRINGE WHEN DEPRESSING PLUNGER ROD. THE 4 RETURN SAMPLES FROM THE OPEN POLY BAG WERE TESTED AND SMALL CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA ONLY FOR ONE SYRINGE. 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# 2213837. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. A DEFINITIVE ROOT-CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED LIQUID COMING FROM SYRINGE WHEN DEPRESSING PLUNGER ROD, DURING PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED LIQUID COMING FROM SYRINGE WHEN DEPRESSING PLUNGER ROD, DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407495 RELION INSULIN SYRINGE 3/10ML 29G X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 2213837 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown