BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G X 8 MM 1CC BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 6787369 · Received August 11, 2017

    Report

    Report Number
    1920898-2017-00110
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    July 18, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #6242868. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED ONE LOOSE 1CC, 8MM SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED AN ORANGE PIECE OF MATERIAL ON THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE CANNULA AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF POLYETHYLENE. CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FOREIGN MATTER IN THE FLUID PATHWAY OF A 30 G X 8 MM 1CC BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE. NO MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569833 30 G X 8 MM 1CC BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242868

    Patients

    Seq Age Sex Outcome Treatment
    1 Other