BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15397803 · Received September 10, 2022

    Report

    Report Number
    1920898-2022-00611
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Date of Event
    August 16, 2022
    Report Date
    August 25, 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
    KS
    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. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO AND (3) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THE VERY FIRST SCALE MARK (ZERO POINT) IS NOT PRINTED. THE PHOTO AND RETURNED SAMPLES WERE TESTED AND NO ZERO UNIT SCALE MARKING WAS PRINTED ON THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1242719 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200977068, 200976824] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200977243] NOTED FOR MISSING PRINT BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED MISALIGNED SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: THE VERY FIRST SCALE MARK (ZERO POINT) IS NOT PRINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139020 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