BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15838503 · Received November 21, 2022

    Report

    Report Number
    1920898-2022-00818
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY 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# 1130991. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED HARD PLASTIC INSIDE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED VOICE MESSAGE CALLER STATED FOREIGN MATTER HARD PLASTIC INSIDE BARREL OF SYRINGE. FOUND 3 SYRINGES WITH ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED HARD PLASTIC INSIDE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED VOICE MESSAGE CALLER STATED FOREIGN MATTER HARD PLASTIC INSIDE BARREL OF SYRINGE. FOUND 3 SYRINGES WITH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708008 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1130991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown