BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE CATHETER

    MDR report key: 3902242 · Received June 24, 2014

    Report

    Report Number
    1319211-2014-00094
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    PMA / PMN Number
    K002101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE HAS BEEN DISPOSED OF BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION IN REGARDS TO THE EVENT AND THE PATIENT'S WELL-BEING. COMPLAINT #: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A DRAINAGE CATHETER PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DRAINAGE CATHETER HAD FRACTURED INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION AS IT HAS BEEN DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368480 DRAINAGE CATHETER DRAINAGE CATHETER GBX ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention