BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14950853 · Received July 7, 2022

    Report

    Report Number
    1920898-2022-00435
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 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
    NC, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (3) LOOSE 0.5ML BD INSULIN SYRINGES. THE CUSTOMER REPORTED THAT THE NEEDLE HUB SEPARATED. ALL 3 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE FEATURED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY WITH NO DAMAGE TO THE BARREL TIP. THE REMAINING TWO SYRINGES DID NOT EXHIBIT HUB SEPARATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060364. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE SYRINGE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN SHE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED 1 SYRINGE AFFECTED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE SYRINGE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN SHE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED 1 SYRINGE AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985005 BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 1060364 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown