BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16682881 · Received April 5, 2023

    Report

    Report Number
    1920898-2023-00195
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382904910013
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : NO SAMPLES 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# 2143234. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING LIQUID COMING OUT OF NEEDLE WHEN INSERTING AIR INTO VIALS FOR HER 3 YEAR OLD INJECTIONS. THE INSULIN IS NOW CLOUDY AND DOES NOT WANT TO USE THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING LIQUID COMING OUT OF NEEDLE WHEN INSERTING AIR INTO VIALS FOR HER 3YEAR OLD INJECTIONS. THE INSULIN IS NOW CLOUDY AND DOES NOT WANT TO USE THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242375 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2143234 00382904910013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown