BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II¿ INSULIN SYRINGE

    MDR report key: 16908394 · Received May 10, 2023

    Report

    Report Number
    1920898-2023-00289
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 17, 2023
    Report Date
    August 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS. THE CUSTOMER RETURNED FOUR PHOTOS OF THE 30GX8MM BD SYRINGE. THE CUSTOMER REPORTED THERE WAS AN ODD SYRINGE WITH WHITE SPOTS ON PLUNGER. THE PHOTOS WERE EXAMINED, AND WHITE SPOTTING ON PLUNGER IS DIFFICULT TO CONFIRM BASED UPON THE PHOTOS ALONE, THEREFORE, FOREIGN MATTE ON BARREL CANNOT BE CONFIRMED WITHOUT THE PHYSICAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1340438. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTOS RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOREIGN MATTER ON PLUNGER). ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AND NO SAMPLES WERE RETURNED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED THAT WHITE SPOTS WERE FOUND ON THE BD ULTRA-FINE II¿ INSULIN SYRINGE PLUNGER WHILE STILL IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY REASON FOR EMAILING IS I HAVE FOUND ANOTHER ODD SYRINGE IN A DIFFERENT BAG OF SYRINGES AS YOU CAN SEE THERE IS SOME ODD OFF WHITE SPOTS ON THE PLUNGER AND WAS FOUND IN A SEALED BAG."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE SPOTS WERE FOUND ON THE BD ULTRA-FINE II¿ INSULIN SYRINGE PLUNGER WHILE STILL IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY REASON FOR EMAILING IS I HAVE FOUND ANOTHER ODD SYRINGE IN A DIFFERENT BAG OF SYRINGES AS YOU CAN SEE THERE IS SOME ODD OFF WHITE SPOTS ON THE PLUNGER AND WAS FOUND IN A SEALED BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881258 BD ULTRA-FINE II¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1340438

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown