BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 21166024 · Received January 16, 2025

    Report

    Report Number
    3001845648-2025-00023
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 12, 2024
    Report Date
    February 5, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K171623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171623. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE AS THERE IS AN ADDITIONAL INFORMATION RECEIVED ON 05-FEB-2025.

    Description of Event or Problem · 0

    THIS WAS A CASE OF ENPD (ENDOSCOPIC NASOPANCREATIC DRAINAGE) APPROACHING THE PANCREATIC DUCT. AS THE CATHETER KINKED, THE PROCEDURE WAS COMPLETED USING A GADELIUS NASAL DRAINAGE ENPD TUBE. NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE ADDITIONAL INFORMATION RECEIVED ON 05-FEB-2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. ON 05-FEB-2025 THE FOLLOWING INFORMATION WAS RECEIVED: PHYSICIAN / ASSISTANT FAILS TO SELECT AN APPROPRIATE WIRE GUIDE. "NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791883 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C2107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown