BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NDL,TUOHY EPID,20GX6", METAL STYLET

    MDR report key: 19899792 · Received August 2, 2024

    Report

    Report Number
    1417592-2024-00778
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER NOTIFIED MEDLINE INDUSTRIES, LP ON (B)(6) 2024 THAT THE NEEDLE IN QUESTION WAS NOT A COMPONENT FROM PAIN8010. ACCORDING TO THE CUSTOMER, THE COMPONENT THAT CAUSED THE REPORTED ISSUE CAME FROM A B BRAUN KIT THEREFORE THE INITIAL REPORTED ISSUE IS NOT RELATED TO PAIN8010 OR ANY OTHER PRODUCT MANUFACTURED BY MEDLINE INDUSTRIES, LP.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN ADMINISTERING A "PAIN BLOCK" THE NEEDLE "BROKE INSIDE THE PATIENT'S BACK". THE CUSTOMER REPORTED THE NEEDLE WAS "SUPERFICIAL", REMOVED UNDER "X-RAY GUIDANCE" WITH A "KELLY CLAMP", AND CLOSED WITH "DERMA BOND". THE CUSTOMER REPORTED THE PROCEDURE WAS ABLE TO BE COMPLETED AND AN "ANTIBIOTIC" WAS ADMINISTERED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN ADMINISTERING A "PAIN BLOCK" THE NEEDLE "BROKE INSIDE THE PATIENT'S BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025799 NDL,TUOHY EPID,20GX6", METAL STYLET BSP MEDLINE INDUSTRIES, LP 23H314

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other