BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG

    MDR report key: 12345932 · Received August 19, 2021

    Report

    Report Number
    1920898-2021-00913
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1033456. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-02-02. MEDICAL DEVICE LOT #: 0323172. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-11-18. MEDICAL DEVICE LOT #: 0295065. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-10-21. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG HAD FOREIGN MATTER. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES WITH DUST PARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242669 SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1