BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER SUCTION TUBE 8FR

    MDR report key: 5082494 · Received September 16, 2015

    Report

    Report Number
    2523190-2015-00095
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    June 11, 2015
    Report Date
    August 31, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 10/16/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. DEVICE HISTORY EVALUATION: DHR REVIEW. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: THERE IS NO APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS (MEDWATCH #(B)(4)) THAT A FRAZIER 8 FR WITH CONTROL VENT BROKE INTO 3 PIECES WHILE IN THE FIELD. SURGEON WAS NOTIFIED AND THROUGH HOMEOSTASIS, IRRIGATION AND SUCTION THE SURGEON WAS SATISFIED NO PIECES REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611024 FRAZIER SUCTION TUBE 8FR M5 - GENERAL SURGERY EQH INTEGRA YORK, PA INC. 072014AZC01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR