BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16441326 · Received February 26, 2023

    Report

    Report Number
    1920898-2023-00069
    Event Type
    Malfunction
    Date Received
    February 26, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 16, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-FEB-2023. INVESTIGATION SUMMARY: THE CUSTOMER RETURNED TWO 0.5ML 31GA SYRINGES REPORTING THAT THERE WAS AN ISSUE WITH THE SYRINGES, ONE OF THE PLUNGERS WAS DEFORMED AND THE SECOND ONE WAS MISSING THE NEEDLE. THE SYRINGES WERE VISUALLY INSPECTED. UPON VISUAL INSPECTION, EMBECTA WAS ABLE TO CONFIRM THAT THE NEEDLE HUB SEPARATES FROM THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2103775. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATES FROM THE BARREL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE PLUNGER DEFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE PLUNGER DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799316 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 2103775 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown