BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7752052 · Received August 6, 2018

    Report

    Report Number
    1920898-2018-00588
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    July 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 07/03/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER DEVICE SINGLE USE?: NO DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE¿VE BEEN USING INSULIN SYRINGES FOR SOME INTRAVITREAL OCULAR INJECTIONS. WE¿VE RECENTLY SEEN AN UPTICK IN THE NUMBER OF FLOATERS IN THE EYE THAT WE THINK MAY BE CAUSED BY THE SILICONE LUBRICANT ON THE SYRINGE AND/OR NEEDLE. WE¿VE USED THESE SYRINGES FOR YEARS WITHOUT MAJOR ISSUES, SO WE¿RE WONDERING IF THE SYRINGES HAVE CHANGED OR IF THESE MAY BE CAUSED BY THE PRODUCTS WE¿RE TESTING" THIS OCCURRED WITH BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) 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. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED "WE¿VE BEEN USING INSULIN SYRINGES FOR SOME INTRAVITREAL OCULAR INJECTIONS. WE¿VE RECENTLY SEEN AN UPTICK IN THE NUMBER OF FLOATERS IN THE EYE THAT WE THINK MAY BE CAUSED BY THE SILICONE LUBRICANT ON THE SYRINGE AND/OR NEEDLE. WE¿VE USED THESE SYRINGES FOR YEARS WITHOUT MAJOR ISSUES, SO WE¿RE WONDERING IF THE SYRINGES HAVE CHANGED OR IF THESE MAY BE CAUSED BY THE PRODUCTS WE¿RE TESTING" THIS OCCURRED WITH BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595484 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other