BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13759753 · Received March 14, 2022

    Report

    Report Number
    1920898-2022-00158
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H.6. INVESTIGATION: 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# 1242719. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE RUBBER STOPPER IS CROOKED/DAMAGED. SHE DESCRIBED IT AS BEING BENT OVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE RUBBER STOPPER IS CROOKED/DAMAGED. SHE DESCRIBED IT AS BEING BENT OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281590 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 1242719 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown