BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

    MDR report key: 9376784 · Received November 26, 2019

    Report

    Report Number
    1920898-2019-01335
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059455
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140530. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE SAFETY MECHANISM DOES NOT CLOSE WITH A BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFETY MECHANISM DOES NOT CLOSE.

    Additional Manufacturer Narrative · 1

    "THE CUSTOMER REPORTED A POSSIBLE LOT NUMBER TO BE INVOLVED. MEDICAL DEVICE LOT #: 9140530, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-20 . " 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 DURING USE THE SAFETY MECHANISM DOES NOT CLOSE WITH A BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFETY MECHANISM DOES NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174952 BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE SEE H.10 30382903059455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other