BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12FR ENDO TB FOR ENDOSCPIC PLC

    MDR report key: 4130422 · Received September 30, 2014

    Report

    Report Number
    9612030-2014-00058
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    May 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT ORIGINALLY KNOWN; HOWEVER, BASED ON THE SAMPLE RECEIVED THE LOT NUMBER IS 319784664X THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE MANUFACTURE OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. A SAMPLE WAS RECEIVED FOR EVALUATION AND THE INCIDENT REPORTED WAS NOT CONFIRMED. AFTER PERFORMING VISUAL AND DIMENSIONAL INSPECTION THE TORPEDO WAS FOUND WITHIN APPROVED SPECIFICATIONS. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION STATED BY THE CUSTOMER COULD NOT BE DETERMINED. THIS PRODUCT IS NOT RECOMMENDED FOR PATIENTS WHO HAVE ANATOMIC ANOMALIES OR DISEASES OF THE NOSE, THROAT, OR ESOPHAGUS; THIS COULD RESULT IN MALFUNCTION OF THE PRODUCT. BECAUSE NO COMPLAINT TREND EXISTS AND A ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED; THE CORRECTIVE ACTION WILL BE LIMITED TO MANUFACTURING AWARENESS. THE PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA. THE APPROPRIATE PRODUCTION PERSONNEL WERE NOTIFIED ABOUT THE REPORTED ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL ALSO BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE. THE CUSTOMER REPORTS THAT THE DEVICE MOVED AFTER 10 DAYS OF USE AND DURING VOMITING. THE NURSE HAD TO REMOVE THE NASOGASTRIC TUBE FROM THE PATIENT. BUT SHE NOTICED THAT THE WEIGHTED OLIVE OF THE DEVICE WAS STUCK INSIDE THE NASAL CONCHA. THE DEVICE HAD TO BE REMOVED UNDER GENERAL ANAESTHESIAS AS IT WAS VERY PAINFUL UNDER LOCAL ANAESTHESIA. THE INCIDENT WAS DUE TO THE SIZE OF THE OLIVE THAT SEEMED TO BIG. NO FURTHER CONSEQUENCES FOR THE PATIENT. IT WAS MORE CLEARLY DEFINED BY THE COVIDIEN CLINICIAN AS; IT APPEARS THAT THE PATIENT WAS VOMITING SO MUCH SO THAT THE NG TUBE MOVED. WHEN THE NURSE WAS REMOVING THE WEIGHTED TUBE- IT BECAME STUCK IN THE PATIENT NARE (NOSE) AND COULD NOT BE PULLED OUT. THIS COULD BE POSSIBLE DUE TO NARROWED NASAL SEPTUM. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO REMOVE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609457 12FR ENDO TB FOR ENDOSCPIC PLC FEEDING TUBE FPD COVIDIEN 8884752505 319784664X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other