BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    MDR report key: 10970031 · Received December 8, 2020

    Report

    Report Number
    1920898-2020-01681
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 12, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE UNKNOWN BATCH NUMBER, NO DHR REVIEW CAN BE COMPLETED. 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 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 WAS UNABLE TO DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328440 BATCH NO: UNKNOWN (REPORTED 0203534). IT WAS REPORTED THAT THE INSULIN SYRINGE IS NOT DRAWING UP ANY PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 WAS UNABLE TO DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328440 BATCH NO: UNKNOWN (REPORTED 0203534). IT WAS REPORTED THAT THE INSULIN SYRINGE IS NOT DRAWING UP ANY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429014 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 UNKNOWN 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1