BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16562325 · Received March 16, 2023

    Report

    Report Number
    1920898-2023-00138
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 21, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: 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: (B)(6) 2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED ONE SYRINGE WITH THE HUB SEPARATED AND STACKED IN THE SHIELD. IT WAS REPORTED BY THE CONSUMER THAT APPROXIMATELY 6 SYRINGE NEEDLE HUBS SEPARATED WHEN REMOVING NEEDLE SHIELD AND NEEDLE SHIELD HARD TO REMOVE. THE HUB WAS PLACED BACK TO THE SYRINGE DURING THE INVESTIGATION AND THERE WERE NO ISSUES WHEN REMOVING THE SHIELD. THEN THE SHIELD TEST WAS APPLIED USING THE CHATILLON TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.3 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER SHIELD REMOVAL FORCE (LBS.) SAMPLE 1 3.318 THE SYRINGE WAS TESTED WITHIN THE SPECIFIED ACCEPTANCE RANGE. HENCE, THE ALLEGED ISSUE SHIELD DOES NOT DETACH COULD NOT BE CONFIRMED BASED ON THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2010787. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SINCE THE ISSUE COULD NOT BE CONFIRMED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 SYRINGE NEED HUB SEPARATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 SYRINGE NEED HUB SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742017 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2010787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown