BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16492827 · Received March 6, 2023

    Report

    Report Number
    1920898-2023-00095
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 7, 2023
    Report Date
    June 9, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 22-MAR-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) SYRINGE 0.3ML 31GA 6MM LOOSE. CONSUMER REPORTED FOUND 3 SYRINGES WITH LIQUID THAT CAME OUT OF NEEDLE BEFORE USE. THE ONE RETURN SAMPLE WAS TESTED AND SMALL CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2143234 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. A DEFINITIVE ROOT-CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN LIQUID CAME OUT OF THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 SYRINGES WITH LIQUID THAT CAME OUT OF NEEDLE BEFORE USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN LIQUID CAME OUT OF THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 SYRINGES WITH LIQUID THAT CAME OUT OF NEEDLE BEFORE USE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683973 BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 2143234 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown