BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 12508759 · Received September 21, 2021

    Report

    Report Number
    1213809-2021-00645
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN PROVIDED: D.4. MEDICAL DEVICE LOT #: 0148670; D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31; H.4. DEVICE MANUFACTURE DATE: 2020-05-27; D.4. MEDICAL DEVICE LOT #: 0149427; D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31; H.4. DEVICE MANUFACTURE DATE: 2020-05-28.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SYRINGE HAS PLASTIC DEFORMATION."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 10ML LL BNS HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SYRINGE HAS PLASTIC DEFORMATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405316 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1