BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17344987 · Received July 18, 2023

    Report

    Report Number
    1920898-2023-00449
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-AUG-2023 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) 0.3ML 31GA 6MM SYRINGE IN AN OPEN POLYBAG FROM THE LOT# 2213816. IT WAS REPORTED BY THE CONSUMER THAT NEEDLE IS BENT AND DO NOT ALLOW ANY LIQUID TO GO THROUGH. CONSUMER ALSO STATED THAT THE NEEDLE HUB IS DAMAGED. THE RETURNED SAMPLES VISUALLY VERIFIED AND OBSERVED NO DAMAGES. FUNCTIONALITY TEST WAS PERFORMED AND OBSERVED NO ISSUES. NO ISSUES OF ANY KIND WAS OBSERVED ON THE RETURNED SAMPLES. THEREFORE, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED ISSUES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB IS DAMAGED AND "APPEARS TO BE BURNT/MELTED". 2 OF 2 ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER ALSO STATED THAT THE NEEDLE HUB IS DAMAGED, APPEARED TO BE BURNT/MELTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB IS DAMAGED AND "APPEARS TO BE BURNT/MELTED". 2 OF 2 ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER ALSO STATED THAT THE NEEDLE HUB IS DAMAGED, APPEARED TO BE BURNT/MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144814 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HYPDERMIC SINGLE LUMEN NEEDLE FMF BD MEDICAL - DIABETES CARE 324909 2213816 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown