BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8805146 · Received July 18, 2019

    Report

    Report Number
    1920898-2019-00684
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    May 21, 2019
    Report Date
    August 22, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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# 8266732. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY SHIELD DID NOT ENGAGE AFTER USE WITH A BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY GLIDE DID NOT LOCK IN PLACE.

    Additional Manufacturer Narrative · 1

    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 SAFETY SHIELD DID NOT ENGAGE AFTER USE WITH A BD SYRINGE SFTYGLD 1 ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY GLIDE DID NOT LOCK IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599342 BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE 8266732 30382903059455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other