BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13760346 · Received March 14, 2022

    Report

    Report Number
    1920898-2022-00161
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1172350; MEDICAL DEVICE EXPIRATION DATE: 2026-07-31; DEVICE MANUFACTURE DATE: 2021-06-21. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN.

    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# 1172350. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED AN UNSPECIFIED NUMBER OF CASES WHERE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED WHEN HE REMOVES NEEDLE SHIELD, NEEDLE HUB WILL SEPARATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED AN UNSPECIFIED NUMBER OF CASES WHERE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED WHEN HE REMOVES NEEDLE SHIELD, NEEDLE HUB WILL SEPARATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281632 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 SEE H10 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown