BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16142090 · Received January 11, 2023

    Report

    Report Number
    1920898-2022-00922
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 22, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0203534. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0203534 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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 THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE SYRINGE AND REMAINED IN THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER RETURNED MY CALL, STATED THAT THE NEEDLE HUB OF ONE SYRINGE SEPARATED AND STAYED INSIDE OF THE SHIELD."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE SYRINGE AND REMAINED IN THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER RETURNED MY CALL, STATED THAT THE NEEDLE HUB OF ONE SYRINGE SEPARATED AND STAYED INSIDE OF THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418981 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0203534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown