BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/4"

    MDR report key: 18970594 · Received March 25, 2024

    Report

    Report Number
    1035907-2024-00010
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 25, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221264272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT UPDATE: RECEIVED UPDATE ON 03-APR-2024: UNFORTUNATELY WE WERE UNSUCCESSFUL IN REMOVING THE NEEDLE FROM THE PATIENT AS THE AREA INVOLVED IS TOO LARGE. RECEIVED UPDATE ON 05-APR-2024: AT THE MOMENT, WE ARE NOT SURE. IT HAS MIGRATED AND IS QUITE DEEP. HE HAD SOME SCIATICA TYPE PAIN AND WE FELT THAT IT COULD BE RELATED TO THE NEEDLE. FORTUNATELY THE PAIN HAS RESOLVED. I HAVE SOUGHT THE OPINION OF A SPINAL SURGEON IN THE INTERIM AND CURRENTLY WAITING FOR THAT APPOINTMENT. THERE HAS NOT BEEN AN ADDITIONAL UPDATE ON THE PATIENT STATUS SINCE THE UPDATE FROM 05-APR-2024. THE COMPLAINT WILL BE UPDATED IF NEW PATIENT STATUS INFORMATION IS PROVIDED. INVESTIGATION: A LOT SEARCH WAS PERFORMED AND THERE ARE NO SIMILAR COMPLAINTS FOR PRODUCT 26427 LOT 191130. THE FREQUENCY OF OCCURRENCE IS REMOTE AND THE SEVERITY OF HARM IS MODERATE FOR AN OVERALL ACCEPTABLE RISK. NO FURTHER ACTION REQUIRED. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED AS PART OF COMPLAINT MONITORING. (B)(6).

    Additional Manufacturer Narrative · 0

    PER INVESTIGATIVE REPORT RECEIVED ON 15-MAR-2024: RETAINED SAMPLES WERE TESTED AND BATCH RECORDS WERE REVIEWED WITH NO OBSERVED ISSUES. THE NEEDLE BREAKAGE COULD EITHER BE CAUSED BY IMPROPER USE OR INSUFFICIENT ADHESIVE BETWEEN NEEDLE AND NEEDLE HUB. CURRENTLY THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHICH WAS THE EXACT CAUSE. ON 19-MAR-2024, RECEIVED ADDITIONAL INFORMATION: IT WAS REPORTED THAT ON (B)(6) 2024, A NEEDLE BROKE IN A PATIENT DURING USE. THE NEEDLE BROKE FROM THE BASE, AND A SECONDARY SURGERY IS BEING PLANNED TO REMOVE THE NEEDLE. THE DEVICE WILL NOT BE RETURNED AND NO PICTURES CAN BE PROVIDED.

    Description of Event or Problem · 0

    NEEDLE BROKE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27671 EXEL HYPO NDL 27GX1-1/4" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 26427 191130 20221264272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention