BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15174729 · Received August 5, 2022

    Report

    Report Number
    1920898-2022-00514
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 8, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 01-AUG-2022. H.6. INVESTIGATION SUMMARY: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 1242749 FOR PRINTING (MISSING SCALE MARKINGS). CUSTOMER RETURNED A SINGLE 0.5ML SYRINGE. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. THE SYRINGE¿S GRADUATION MARKINGS AND THERE WAS NO EVIDENCE OF MISSING GRADUATION MARKINGS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242749. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SCALE MARKINGS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THAT 1 SYRINGE WAS WITHOUT MARKINGS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITHOUT MARKINGS ON THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THAT 1 SYRINGE WAS WITHOUT MARKINGS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITHOUT MARKINGS ON THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468787 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE 324911 1242749 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown