BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16056434 · Received December 27, 2022

    Report

    Report Number
    1920898-2022-00904
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 7, 2022
    Report Date
    January 20, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. THE CUSTOMER RETURNED A PHOTO OF THE 31GX6MM BD INSULIN SYRINGES FROM LOT# 1242719. THE CUSTOMER REPORTED THAT MANY SYRINGES WERE FOUND WITH INACCURATE SCALE MARKS. THE FIRST(ZERO) SCALE OF THE SYRINGE WAS LOWER THAN IT SHOULD BE. THE PHOTO WAS EXAMINED, AND THERE SEEMS TO BE A SLIGHT MISALIGNMENT ON THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242719. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTO RECEIVED (SCALE MISALIGNED). H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1016653. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. DEVICE MANUFACTURE DATE: 16-JAN-2021. MEDICAL DEVICE LOT #: 1144160. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. DEVICE MANUFACTURE DATE: 24-MAY-2021. MEDICAL DEVICE LOT #: 1242719. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. DEVICE MANUFACTURE DATE: 30-AUG-2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 200 OF THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAVE INACCURATE SCALE MARKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: AND THE CUSTOMER ALSO FOUND MANY SYRINGES WITH INACCURATE SCALE MARKS. THE FIRST(ZERO) SCALE OF THE SYRINGE WAS LOWER THAN IT SHOULD BE. THERE ARE SO MANY THAT IT IS DIFFICULT TO ASCERTAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 200 OF THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAVE INACCURATE SCALE MARKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: AND THE CUSTOMER ALSO FOUND MANY SYRINGES WITH INACCURATE SCALE MARKS. THE FIRST(ZERO) SCALE OF THE SYRINGE WAS LOWER THAN IT SHOULD BE. THERE ARE SO MANY THAT IT IS DIFFICULT TO ASCERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108672 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown