BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE SYRINGE

    MDR report key: 22967612 · Received September 4, 2025

    Report

    Report Number
    2243072-2025-01090
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 14, 2025
    Report Date
    January 12, 2026
    Manufacturer
    EMBECTA MEDICAL I LLC
    Product Code
    FMF
    UDI-DI
    00382903033270
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 97 UNUSED NEEDLES WITH SYRINGE (MATERIAL# 303327 BATCH # 3100484F) WERE RECEIVED AND ANALYZED BY OUR QUALITY TEAM WITH THE CUSTOMER'S COMPLAINT OF LEAKAGE DURING USE. THE UNUSED SAMPLES WERE TESTED BY DRAWING SALINE SOLUTION AND INJECTING IT WITH RESISTANCE AND THERE WERE NO LEAKS IN ANY OF THE 97 SAMPLES. THE SAMPLES WERE THEN ANALYZED UNDER HIGH POWER MICROSCOPE TO SEARCH FOR ABNORMALITIES AND NO SYRINGES PRESENTED WITH ISSUES. THE COMPLAINT COULD NOT BE VERIFIED AND THE ROOT CAUSE REMAINS UNKNOWN WITHOUT THE ORIGINAL AFFECTED SAMPLES.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. LOT NUMBER WAS INCORRECT IN THE INITIAL MDR, CORRECT LOT NUMBER IS 3100484.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE SAFETYGLIDE 1ML W/NDL 27X3/8 IB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303327, BATCH # 100484F1. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM DESCRIPTION: SAFETYGLIDE TB SYR-NEEDLE, VNDR ITEM#: 303327, LOT#: 100484F1, QUANTITY: 1, UOM: 100/BX, CMT: LEAKING, ADTL.CMTS: EXP - 04/30/28.

    Description of Event or Problem · 0

    SAMPLES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852035 BD SAFETYGLIDE SYRINGE SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC 3100484 00382903033270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown