BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 17564626 · Received August 17, 2023

    Report

    Report Number
    3001845648-2023-00637
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 19, 2023
    Report Date
    November 30, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002217253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K180868. DEVICE EVALUATION 01 ENBD-6-LIGUORY DEVICE OF LOT C1908983 WAS RETURNED TO CIRL OPENED IN ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION LAB EVALUATION DATE: 17/AUGUST/2023. VISUAL INSPECTION: CATHETER, INTRODUCER RETURNED, CATHETER IN MULTIPLE PIECES ,OBVIOUS SIGNS OF CUTTING/DAMAGE. FUNCTIONAL INSPECTION: N/A. DOCUMENT REVIEW. PRIOR TO DISTRIBUTION ALL ENBD-6-LIGUORY DEVICES ARE SUBJECT TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C1908983 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. THE FAILURE HAS NOT PREVIOUSLY OCCURRED WITH LOT C1908983. BASED ON THE INFORMATION TO DATE, THERE ARE NO MANUFACTURING ISSUES ASSOCIATED WITH LOT C1908983. THE INSTRUCTIONS FOR USE (IFU0129) HIGHLIGHTS THE INTENDED USE: THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. THE USER IS INSTRUCTED, DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE AND USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THE DEVICE WAS TO BE USED AS AN ASPIRATION CATHETER FOR STOMACH FLUID. THIS OUTSIDE THE INTENDED USE OF THE DEVICE - TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. THE DEVICE WAS MODIFIED PRIOR TO USE BY CUTTING THE TIP, THIS LED TO THE PLASTIC BEGINNING TO CRACK AND SHATTER. COOK IRELAND DO NOT RECOMMEND MAKING MODIFICATIONS TO THE DEVICE PRIOR TO USE AS THE EFFECTS OF USING SUCH A DEVICE CANNOT BE DETERMINED. COMPLAINT CONFIRMATION. THE COMPLAINT IS CONFIRMED BASED ON THE VISUAL AND/OR FUNCTIONAL INSPECTION. SUMMARY. THE COMPLAINT IS CONFIRMED BASED ON THE VISUAL AND/OR FUNCTIONAL INSPECTION. FAILURE IDENTIFIED: OFF LABEL USE AND USER ERROR - 01 DEVICE CONFIRMED PRIOR TO USE. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE AND USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THE DEVICE WAS TO BE USED AS AN ASPIRATION CATHETER FOR STOMACH FLUID. THIS OUTSIDE THE INTENDED USE OF THE DEVICE - TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. THE DEVICE WAS MODIFIED PRIOR TO USE BY CUTTING THE TIP, THIS LED TO THE PLASTIC BEGINNING TO CRACK AND SHATTER. COOK IRELAND DO NOT RECOMMEND MAKING MODIFICATIONS TO THE DEVICE PRIOR TO USE AS THE EFFECTS OF USING SUCH A DEVICE CANNOT BE DETERMINED. ACCORDING TO THE INITIAL REPORTER, THIS OCCURRENCE WAS PRIOR TO PATIENT CONTACT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 30-NOV-2023.

    Description of Event or Problem · 0

    THE DEVICE WAS TO BE USED OFF LABEL AS AN ASPIRATION CATHETER FOR STOMACH FLUID. THE DEVICE WAS MODIFIED BY CUTTING THE TIP, AND THE PLASTIC BEGAN TO CRACK AND SHATTER. THE PRODUCT WAS STORED FOR SEVERAL MONTHS IN THE STORE ROOM UNDER DIRECT FLUORESCENT LIGHTING. THERE WERE NO ADVERSE EFFECTS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SIZE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792062 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1908983 10827002217253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown