BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15818852 · Received November 17, 2022

    Report

    Report Number
    1920898-2022-00812
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 12, 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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES AND D10: RETURNED TO MANUFACTURER ON: 03-NOV-2022. INVESTIGATION SUMMARY: CUSTOMER RETURNED (50) SYRINGE SAMPLES FROM LOT# 1242719, (4) SYRINGE SAMPLES FROM LOT# 1347417, AND (31) SYRINGE SAMPLES FROM LOT# 1214676. ALL RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT A CLEAR LIQUID CAME OUT OF THE CANNULA FROM 1 OF THE SYRINGES FROM EACH RETURNED LOT. A SMALL PORTION OF THE LIQUID WAS REMOVED THEN PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SILICONE. SAMPLES FROM EACH LOT WERE FORWARDED TO MANUFACTURING (HOLDREGE) FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#S 1347417, 1242719, 1214676. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1347417 MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026 DEVICE MANUFACTURE DATE: 13-DEC-2021. MEDICAL DEVICE LOT #: 1242719 MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026 DEVICE MANUFACTURE DATE: 30-AUG-2021. MEDICAL DEVICE LOT #: 1214676 MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026 DEVICE MANUFACTURE DATE: 02-AUG-2021. INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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 1 BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EACH FROM LOTS 1347417, 1242719, AND 1214676 HAD EXCESSIVE LUBRICANT ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THAT THERE WAS SAME PROBLEM(EXCESSIVE LUBRICANT) IN THE COMPENSATION SAMPLES. THE LOT# IS 1347417. ALSO THE CUSTOMER SENT ANOTHER LOT#(1242719) SYRINGES WITH THE SAME PROBLEM(EXCESSIVE LUBRICANT)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EACH FROM LOTS 1347417, 1242719, AND 1214676 HAD EXCESSIVE LUBRICANT ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THAT THERE WAS SAME PROBLEM(EXCESSIVE LUBRICANT) IN THE COMPENSATION SAMPLES. THE LOT# IS 1347417. ALSO THE CUSTOMER SENT ANOTHER LOT# (1242719) SYRINGES WITH THE SAME PROBLEM(EXCESSIVE LUBRICANT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212173 BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H10 00382904910013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown