BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8404836 · Received March 8, 2019

    Report

    Report Number
    1920898-2019-00238
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 2, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THERE WAS ONE (1) BATCH OF MATERIAL# 700005654 (SYRINGE 0.3ML ASM 31G 6MM TW SM700179 SC) WHICH WAS CONSUMED INTO FINAL PRODUCT BATCH# 8043556. THERE WAS ONE (1) NOTIFICATION [200746694] NOTED FOR SCRATCHED PRINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE "SLANTED", AND NOTICED DURING USE. AS REPORTED BY THE CUSTOMER, "CONSUMER REPORTED SCALE PRINT IS INCORRECT, STATED THAT THE UNIT MARKINGS ARE SLANTED, DOES NOT RE-USE. LOT # 8043556, PRODUCT # 324909, EXP 03-31-2023. OCCURRENCE DATE IS UNKNOWN. SENDING MAIL KIT AND PRODUCT VOUCHER."

    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 THE SCALE MARKINGS ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WERE "SLANTED", AND NOTICED DURING USE. AS REPORTED BY THE CUSTOMER, "CONSUMER REPORTED SCALE PRINT IS INCORRECT, STATED THAT THE UNIT MARKINGS ARE SLANTED, DOES NOT RE-USE. LOT # 8043556, PRODUCT # 324909, EXP 03/31/2023. OCCURRENCE DATE IS UNKNOWN. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195767 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8043556

    Patients

    Seq Age Sex Outcome Treatment
    1 Other