BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16747007 · Received April 14, 2023

    Report

    Report Number
    1920898-2023-00227
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 27, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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: 08-MAY-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2 ML SYRINGE IN AN OPEN POLYBAG FROM LOT# 2038577. IT WAS REPORTED THAT SYRINGE IN A BAG THAT WAS CRUSHED/DAMAGED NO NEEDLE. RETURNED SAMPLE VISUALLY EXAMINED AND OBSERVED DAMAGED SYRINGE WITH MISSING CANNULA HUB. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2020067. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. ROOT -CAUSE: NA H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN HE REMOVED THE NEEDLE SHIELD, THE NEEDLE AND PART THAT NEEDLE IS ATTACHED TO CAME OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN HE REMOVED THE NEEDLE SHIELD, THE NEEDLE AND PART THAT NEEDLE IS ATTACHED TO CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280002 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMF BD MEDICAL - DIABETES CARE 2020067

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown