BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/2"

    MDR report key: 19102279 · Received April 12, 2024

    Report

    Report Number
    1035907-2024-00014
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    February 15, 2021
    Report Date
    April 5, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221264265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: SINCE THERE ARE NO ABNORMALITIES FOUND IN THE RETAIN SAMPLES OF THE AFFECTED LOT THAT MAY CAUSE THE CANNULA TO BREAK OR FALL OFF AND THERE ARE NO DEFECTIVE PRODUCT SAMPLES, PICTURES OR VIDEO AVAILABLE FOR REVIEW, THE PROBABLE ROOT CAUSE IS DETERMINED TO BE THAT THE NEEDLE TUBE WAS BENT EXCEEDING THE TOLERANCE OF THE NEEDLE TUBE CLINICAL USE. BASED ON PRODUCT SPECIFICATION FOR CLINICAL USE, IF THE BENDING EXCEEDS 20° OR THE NEEDLE DEFLECTION EXCEEDS THE >0.340MM LIMIT DURING CLINICAL USE, THERE IS A RISK OF BREAKAGE. CAPA-33 WAS INITIATED TO INVESTIGATE AND IMPLEMENT METHODS TO ADDRESS NEEDLE BENDING EXCEEDING TOLERANCE. ROOT CAUSE: UNCONFIRMED, PROBABLE - NEEDLE BEND EXCEED TOLERANCE (B)(4)

    Description of Event or Problem · 0

    THE FOLLOWING IS A LEGACY COMPLAINT (B)(4) THAT WAS INVESTIGATED AND CLOSED IN 2021 BUT IS BEING RE-OPENED IN (B)(4) BECAUSE THE INCIDENT SHOULD HAVE ORIGINALLY BEEN A REPORTABLE EVENT. REFERENCE CAPA-34 FOR EXPLANATION. ON 15-FEB-2021 THE FOLLOWING ALLEGED DEFICIENCY WAS REPORTED TO EXEL BY THE RE-SELLER: "THE CUSTOMER REPORTS THAT AS THEY WERE USING THE EXEL HYPODERMIC NEEDLE TO NUMB A FEMALE PATIENT FOR A PELLET INSERTION PROCEDURE WHEN THE NEEDLE BROKE OFF INSIDE THE PATIENT AT THE HUB. THIS REQUIRED A VISIT TO THE ER WHERE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND HAD SURGERY TO REMOVE THE NEEDLE FROM THE HIP AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412431 EXEL HYPO NDL 27GX1-1/2" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 26426 191130 20221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention