BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 17213708 · Received June 27, 2023

    Report

    Report Number
    1920898-2023-00401
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. CUSTOMER RETURNED TWO PHOTOS OF 31GX8MM SYRINGE. THE CONSUMER REPORTED THAT ONE BOX WAS DAMAGED, SHORT PACKING AND DEFECTIVE SYRINGE. THE PHOTOS WERE EXAMINED AND EXHIBITS THE NEEDLE SHIELD IN THE POLYBAG SEPARATED FROM THE CANNULA, A POLYBAG DISPLAYING ONLY FOUR SYRINGES IN AN OPEN POUCH AND A SHELF CARTON WHICH APPEARS TO BE IN GOOD CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2192462. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTOS RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE IDENTIFIED.

    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 PRIOR TO USE WITH BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE THE CAP WAS NOT ON THE SYRINGE IN THE POLY BAG, THUS AFFECTING STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE SYRINGE. BASED ON PHOTO, THE CAP WAS OFF THE SYRINGE IN THE POLY BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE THE CAP WAS NOT ON THE SYRINGE IN THE POLY BAG, THUS AFFECTING STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE SYRINGE. BASED ON PHOTO, THE CAP WAS OFF THE SYRINGE IN THE POLY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571016 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2192462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown