BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE

    MDR report key: 6947093 · Received October 12, 2017

    Report

    Report Number
    1920898-2017-00233
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 12, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (90) 1/2CC, 12.7MM, 29G SYRINGES IN SEALED POLY BAGS WITH THE SHELF CARTON FROM LOT # 6172630. CUSTOMER STATES THAT SILICONE FROM THE SYRINGE WAS INJECTED INTO THE EYE OF SEVERAL PATIENTS. THIRTY OUT OF 90 RETURNED SYRINGES WERE EXAMINED VISUALLY AND UNDER THE MICROSCOPE AND NO FOREIGN MATTER WAS OBSERVED ON OR IN ANY OF THE SAMPLES. ALL OF THESE SAMPLES WERE ALSO TESTED AND NO MATERIAL CAME OUT OF THE SYRINGE WHEN FULLY DEPRESSING THE PLUNGER ROD. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172630. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN MEDICATION INJECTED FROM A 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE PARTICLES OF SILICON FROM THE SYRINGE WERE ALSO INJECTED INTO THE EYES OF PATIENTS. INJURY AND MEDICAL INTERVENTION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723090 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6172630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other