BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ INSULIN SYRINGE

    MDR report key: 7939268 · Received October 5, 2018

    Report

    Report Number
    1920898-2018-00766
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 19, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8010798. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200730000] NOTED FOR SPINNNERS SEVERITY: S_3__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 8010798. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE STICK INJURY. WHEN SAFETY MECHANISM WAS ACTIVATED IT BROKE CAUSING A DIRTY NEEDLE STICK INJURY. THE DEVICE USER WAS DIRECTED TO A DOCTOR FOR EXPOSURE SCREENING. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE STICK INJURY. WHEN SAFETY MECHANISM WAS ACTIVATED IT BROKE CAUSING A DIRTY NEEDLE STICK INJURY. THE DEVICE USER WAS DIRECTED TO A DOCTOR FOR EXPOSURE SCREENING. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778125 BD¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 8010798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention