BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 23723382 · Received December 4, 2025

    Report

    Report Number
    2243072-2025-01452
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    January 12, 2026
    Manufacturer
    EMBECTA MEDICAL I LLC
    Product Code
    MEG
    UDI-DI
    00382903059355
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    4 PHOTOS WERE RECEIVED AND ANALYZED BY OUR QUALITY TEAM WITH THE CUSTOMER'S COMPLAINT OF SAFETY MECHANISM FAILURE. THE PHOTOS VERIFIED THE COMPLAINT AS THE SAFETY SHIELD WAS COMPLETELY SEPARATED FROM THE SYRINGE BARREL ASSEMBLY. THE ROOT CAUSE OF THIS ISSUE IS OPERATOR ERROR AT TIME OF SAFETY MECHANISM TO SYRINGE ASSEMBLY DUE TO IMPROPER SETTING OF SAFETY MECHANISM TO SYRINGE. CORRECTIVE ACTION IS NOT POSSIBLE DUE TO THE ASSEMBLY LINE BEING SHUT DOWN DURING PLANT CLOSURE. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE THE DEVICE PRODUCTION HISTORY BUT DUE TO PLANT CLOSURE THE RECORDS COULD NOT BE OBTAINED. IF THERE WERE QUALITY ALERTS OR ABNORMALITIES FOR THIS LOT# THESE WOULD BE EVIDENT AND REPORTED. IN THIS CASE QUALITY DEFECTS IN THIS LOT ARE UNLIKELY.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305935, BATCH#: 4163120. RCC RECEIVED A COMPLAINT VIA COMMUNITY. WHILE PREPARING TO GIVE INSULIN IT WAS NOTED THAT SYRINGE WAS DEFECTIVE. THE SAFETY MECHANISM WOULD GET STUCK IN THE CAP OR AS YOU WOULD GO TO REMOVE THE CAP TO DRAW UP IT WOULD COME FLYING OFF THE NEEDLE. I CHECKED THE LOT NUMBER AND REALIZED IT WAS LOT#: 4163120N1 AND WE CHECKED A FEW FROM THE LOT AND REALIZED THERE WAS A FEW THAT WERE DEFECTIVE AND SOME WERE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857037 BD SAFETYGLIDE SYRINGE, ANTISTICK MEG EMBECTA MEDICAL I LLC 4163120 00382903059355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown