BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8294911 · Received January 31, 2019

    Report

    Report Number
    1920898-2019-00121
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 16, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240961. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TEN (10) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED FOR MISSING ZERO LINE. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR BLACK BARRELS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED FOR MISSING PRINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR EXCESSIVE INK. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR MISSING SCALE LINES. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR VOLUMES. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD EXTRA SPACE IN THE SYRINGE (ABOUT HALF A UNIT). THIS RESULTED IN THE CONSUMER TAKING TOO MUCH INSULIN, AND GLUCOSE NUMBERS THAT ARE NOT NORMAL. "STATED SHE CALLED THE PARAMEDICS LAST MONTH, (DOES NOT HAVE EXACT DATE) TO CHECK HER NUMBERS. STATED THE PARAMEDIC RAN AN IV WITH GLUCOSE SHE THINKS, TO BRING HER NUMBERS BACK TO NORMAL. SHE DID NOT GO TO HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87311 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7240961 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention