BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17243710 · Received June 30, 2023

    Report

    Report Number
    1920898-2023-00426
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382904909017
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2213816 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE NEEDLE WOULD NOT DRAW THE INSULIN. A SECOND DEVICE WAS USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT REPORTED NEEDLE DID NOT DRAW INSULIN BUT WHEN SHE USED A SECOND SYRINGE, IT WORKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE NEEDLE WOULD NOT DRAW DRAW THE INSULIN. A SECOND DEVICE WAS USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT REPORTED NEEDLE DID NOT DRAW INSULIN BUT WHEN SHE USED A SECOND SYRINGE, IT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255178 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2213816 00382904909017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown