BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 8570973 · Received May 1, 2019

    Report

    Report Number
    1920898-2019-00410
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8211738. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200770655] NOTED FOR MISSING PRINT DAMAGED BARRELS. THERE WAS ONE (1) NOTIFICATION [200769955] NOTED FOR MISSING SCALE LINE. THERE WAS ONE (1) NOTIFICATION [200769886] NOTED FOR DOUBLE PRINT DAMAGED TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS WERE MISALIGNED WITH A BD SYRINGE¿ 0.3ML 31GA 6MM WHOLEUNIT 10 BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SCALE MARKING IS MISALIGNED. VERBATIM: PET OWNER REPORTED THE SCALE MARKINGS/LINES ARE STARTING AT DIFFERENT AREAS ON BARREL OF SYRINGES. STATED SHE WENT THROUGH TWO BOXES WITH THE SAME LOT NUMBER. STATED SHE'S NOT SURE IF SHE'S ADMINISTERING 1 UNIT, LESS OR MORE. STATED HER CAT HAS NOT BEEN AFFECTED BY THE DOSAGE BUT SHE'S CONCERNED. LOT: 8211738, EXPIRATION DATE: 2023-08-31, ITEM: 324909. OCCURRENCE DATE UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 WERE MISALIGNED WITH A BD SYRINGE¿ 0.3ML 31GA 6MM WHOLE UNIT 10 BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SCALE MARKING IS MISALIGNED. VERBATIM: PET OWNER REPORTED THE SCALE MARKINGS/LINES ARE STARTING AT DIFFERENT AREAS ON BARREL OF SYRINGES. STATED SHE WENT THROUGH TWO BOXES WITH THE SAME LOT NUMBER. STATED SHE'S NOT SURE IF SHE'S ADMINISTERING 1 UNIT, LESS OR MORE. STATED HER CAT HAS NOT BEEN AFFECTED BY THE DOSAGE BUT SHE'S CONCERNED. LOT: 8211738, EXPIRATION DATE: 2023-08-31, ITEM: 324909. OCCURRENCE DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361262 BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8211738 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other