BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 27GA 3/8IN IB 25 TRAY 1000

    MDR report key: 20614656 · Received November 5, 2024

    Report

    Report Number
    1920898-2024-00149
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 17, 2024
    Report Date
    February 4, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903055364
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 1 SYRINGE TRAY WITH 1 SYRINGE WAS RECEIVED WITH THE CUSTOMER'S COMPLAINT OF FOREIGN MATTER. THE SYRINGE PLUNGER HAD A RED SUBSTANCE PRESENT THAT VERIFIED THE COMPLAINT. THE SUBSTANCE WAS SCRAPPED FROM SYRINGE PLUNGER AND HAD A GREASE LIKE COMPOSITION THAT WAS SIMILAR TO THAT OF MACHINE LUBRICANT. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) ANALYSES WAS THEN EMPLOYED TO TEST FOR A POSSIBLE MATCH OF THIS MATERIAL AND THE TOP MATCHES WERE THAT OF RED GREASE USED IN MANUFACTURING PLANT MACHINERY. ROOT CAUSE OF THIS FAILURE HAS BEEN TRACED TO AN OPERATOR OMISSION LEADING TO GREASE CONTAMINATION OF THE SYRINGE PLUNGER BEFORE PACKAGING. THE MANUFACTURING TEAM HAS BEEN NOTIFIED OF THIS FAILURE. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    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

    SAMPLE RECEIVED.

    Description of Event or Problem · 0

    MATERIAL # 305536, BATCH # 4033092. IT WAS REPORTED THAT THE BD SYRINGE 0.5ML 27GA 3/8IN IB 25 TRAY 1000 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: MAT# 305536, LOT# 4033092 RED CRYSTALIZED SUBSTANCE ON THE ACTUAL PLUNGER WITH IN THE SYRINGE. NO PATIENT INVOLVEMENT. HAS THE SAMPLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417143 BD SYRINGE 0.5ML 27GA 3/8IN IB 25 TRAY 1000 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 4033092 00382903055364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown