BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/2"

    MDR report key: 18664758 · Received February 7, 2024

    Report

    Report Number
    1035907-2024-00001
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 2, 2024
    Report Date
    March 21, 2024
    Manufacturer
    EXELINT INTERNATIONAL
    Product Code
    FMI
    UDI-DI
    00020221264265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER INVESTIGATION REPORT SENT BY OEM ON 28-FEB-2024 AND 01-MAR-2024: RETENTION SAMPLES WERE TESTED AND PRODUCTION PROCESS RECORDS WERE REVIEWED. NO ISSUES WERE NOTED. THERE ARE NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE AVAILABLE COMPLAINT INFORMATION (NO RETURNED PRODUCT OR COMPLAINT IMAGES), A POTENTIAL ROOT CAUSE IS NO ADHESIVE OR INSUFFICIENT ADHESIVE BETWEEN THE NEEDLE TUBE AND THE NEEDLE HUB. THE MANUFACTURING MACHINE CAN DETECT MISSING ADHESIVE IN REAL TIME. ADDITIONALLY, SAMPLES ARE TESTED FOR ADHESIVE STRENGTH DURING MANUFACTURING, AND A FIRMNESS TEST IS CONDUCTED FOR EACH LOT. THERE IS A LOW PROBABILITY THAT THERE IS NO ADHESIVE OR INSUFFICIENT ADHESIVE THAT WOULD CAUSE THE NEEDLE TUBE TO SEPARATE FROM THE NEEDLE HUB. DUE TO A CLEAN DETACHMENT FROM THE HUB WHEN WITHDRAWING THE NEEDLE, THIS INCIDENT IS NOT RELATED TO THE NEEDLE BREAKING.

    Additional Manufacturer Narrative · 0

    ON 2/7/24 THE CLINIC MANAGER STATED: PER PHYSICIAN AT THE TIME OF THE EVENT FROM WHAT COULD BE SEEN, WAS THAT THE NEEDLE SEEMED TO HAVE A CLEAN DETACHMENT FROM THE HUB WHEN WITHDRAWING THE NEEDLE. DID NOT APPEAR TO HAVE A BREAK. LIDOCAINE WAS INJECTED TO THE RIGHT PARASPINAL LUMBAR MUSCLES, AROUND THE UPPER LUMBAR LEVELS AND NOT DIRECTLY MIDLINE.

    Description of Event or Problem · 0

    PER CLINIC MANAGER: "ON (B)(6) 2024 ONE OF OUR PROVIDER'S REPORTED THE NEEDLE CLEANLY DETACHED ITSELF FROM THE HUB DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF NEEDLE BREAKAGE OR FRACTURE FROM THE HUB. THE NEEDLES WERE PURCHASED FROM MCKESSON." THE FOLLOWING INFORMATION WAS PROVIDED VIA TELEPHONE CONVERSATION BETWEEN EXEL QA SPECIALIST AND THE CLINIC MANAGER: PATIENT WAS AT THE PAIN MANAGEMENT CENTER OF THE HOSPITAL FOR TRIGGER POINT THERAPY TO INJECT LIDOCAINE TO THE SUPERIOR ASPECT OF LUMBAR MIDLINE. IT WAS REPORTED THAT EXEL HYPO NDL 27GX1-1/2" P/N: 26426, LOT #230602 NEEDLE BROKE FROM THE SIRING HUB AND LODGED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER NEEDLE FROM THE SAME LOT. THE PATIENT WAS SENT TO URGENT CARE WHERE THE PHYSICIAN PERFORMED A SUPERFICIAL INCISION AND WAS ABLE TO SUCCESSFULLY REMOVED THE NEEDLE. THE INCISION WAS SUTURED AND THE PATIENT IS STATED TO BE WELL. THE CLINIC MANAGER REPORTED THAT THIS IS THE FIRST INCIDENT WITH A BROKEN NEEDLE AND THAT ITS NOT HAPPENED BEFORE WITH THE SAME OR OTHER BRANDS. NO IMAGES OF THE DAMAGED NEEDLE WERE TAKEN AND NEITHER THE NEEDLE NOR SYRINGE WERE RETAINED. IT WAS STATED THAT THE PT DID NOT HAVE ANY OTHER ISSUES OR DISEASE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226390 EXEL HYPO NDL 27GX1-1/2" HYPODERMIC NEEDLE FMI EXELINT INTERNATIONAL 26426 230602 00020221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H