BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8834071 · Received July 26, 2019

    Report

    Report Number
    1920898-2019-00709
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 5, 2019
    Report Date
    August 16, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9015873. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200797836] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAS BEEN FOUND WITH SAFETY MECHANISM ISSUES AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFETY SLEEVE WOULD NOT ENGAGE. DESCRIPTION: SAFETY ARM WOULD NOT ENGAGE.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE SYRINGE SFTYGLD 1 ML W/NDL 27X1/2 RB HAS BEEN FOUND WITH SAFETY MECHANISM ISSUES AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFETY SLEEVE WOULD NOT ENGAGE. DESCRIPTION: SAFETY ARM WOULD NOT ENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624046 SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE 9015873 30382903059455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other