BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-½"

    MDR report key: 19126330 · Received April 17, 2024

    Report

    Report Number
    1035907-2024-00013
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    May 11, 2021
    Report Date
    April 4, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221264265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. FACTORY NOTIFIED 05/26/2021. (1) 20 SAMPLES FROM THE SAME BATCH WERE VISUALLY INSPECTED AND OBSERVED INDIVIDUALLY, IT WAS PROVED THAT THE CANNULA IS STRAIGHT, THE SURFACE OF THE CANNULA IS NORMAL AND ADHESIVE IS UNIFORM AND FULL. (2) 5 SAMPLES WERE SELECTED FOR CANNULA RIGIDITY AND TOUGHNESS TESTING AND NEEDLE HUB CONNECTION FIRMNESS TESTING AND NO ABNORMAL SITUATION WAS FOUND. 2. THE INSPECTION RESULTS OF THIS BATCH OF INJECTION NEEDLE PRODUCTS MEET THE REQUIREMENTS AND STANDARDS THROUGH THE INSPECTION OF RELEVANT RETAINED SAMPLES AND THE RETROSPECTIVE INVESTIGATION OF THE PRODUCTION PROCESS. 3. ACCORDING TO THE DEVICE PHOTO, THERE ARE TRACES OF ADHESIVE AT THE CANNULA AND NEEDLE HUB, AND THE RESIDUAL CANNULA CAN ALSO BE SEEN IN THE NEEDLE HUB. THEREFORE, THE LACK OF ADHESIVE IS RULED OUT. THE PROBABLE ROOT CAUSE IS THAT THE THICKNESS OF THE NEEDLE TUBE OF THIS INJECTION NEEDLE IS THIN, IF THE BENDING EXCEEDS 20 DEGREES DURING CLINICAL USE THERE IS A RISK OF THE NEEDLE TUBE BREAKING. 4. CAPA-33 WAS INITIATED TO INVESTIGATE AND IMPLEMENT METHODS TO ADDRESS NEEDLE BENDING EXCEEDING TOLERANCE. (B)(4).

    Description of Event or Problem · 0

    UPON REVIEW, THIS IS A LEGACY COMPLAINT(C190204) THAT WAS INVESTIGATED AND CLOSED IN 2021 BUT IS BEING RE-OPENED IN QUALIO BECAUSE THE INCIDENT SHOULD HAVE ORIGINALLY BEEN A REPORTABLE EVENT. REFERENCE CAPA-34 FOR EXPLANATION. ON THE 20-MAY-2021 A PRODUCT COMPLAINT WAS EMAILED TO EXEL FROM AIR-TITE PRODUCTS REGARDING PRODUCT #26426 - EXEL HYPODERMIC NEEDLE 27G X1-1/2" , LOT # 190910. THE CUSTOMER STATES, "I HAVE ATTACHED A PICTURE AND A PRELIMINARY COMPLAINT REPORT (AT 2021.0143) CONCERNING AN EXEL 26426 27GX1.5" NEEDLE WHICH WAS EITHER BROKEN OR DISENGAGED FROM THE HUB DURING A TRIGGER POINT INJECTION(BUTTOCKS) OF A 39-YEAR-OLD FEMALE. THE REPORT SHOWS THAT THE PATIENT WAS REFERRED TO THE LOCAL EMERGENCY ROOM FOR TREATMENT BY THE OFFICE NURSE PRACTITIONER. SUBSEQUENTLY, A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE NEEDLE REMNANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341415 EXEL HYPO NDL 27GX1-½" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 26426 190910 20221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown Hospitalization