BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA

    MDR report key: 11617161 · Received April 5, 2021

    Report

    Report Number
    1920898-2021-00380
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    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. 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 0.5ML 28GA 1/2IN BLS 500CAS CA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461 BATCH NO: 0132264. IT WAS REPORTED THAT A BEAD OF LIQUID WAS COMING OUT OF THE SYRINGE UPON OPENING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514171 SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132264

    Patients

    Seq Age Sex Outcome Treatment
    1