BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II¿ SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 8420867 · Received March 14, 2019

    Report

    Report Number
    1920898-2019-00255
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 26, 2019
    Report Date
    March 18, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043594. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE II¿ SELF-CONTAINED INSULIN SYRINGES WERE CRACKED. CUSTOMER¿S VERBATIM: ¿ PHARMACIST REPORTED ON BEHALF OF CONSUMER THAT SOME OF THE SYRINGES WERE CRACKED. OCCURRENCE DATE IS UNKNOWN, LOT # 8043594, PRODUCT # 320468, EXP 02-2023. PHARMACIST REPLACED THE PRODUCT, SENDING REPLACEMENT AND MAIL KIT TO PHARMACY.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD ULTRA-FINE II¿ SELF-CONTAINED INSULIN SYRINGES WERE CRACKED. CUSTOMER¿S VERBATIM: ¿ PHARMACIST REPORTED ON BEHALF OF CONSUMER THAT SOME OF THE SYRINGES WERE CRACKED. OCCURRENCE DATE IS UNKNOWN, LOT # 8043594, PRODUCT # 320468, EXP 02-2023. PHARMACIST REPLACED THE PRODUCT, SENDING REPLACEMENT AND MAIL KIT TO PHARMACY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216487 BD ULTRA-FINE II¿ SELF-CONTAINED INSULIN SYRINGE INSULIN SYRINGE AND NEEDLE FMI BD MEDICAL - DIABETES CARE 8043594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other