BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALEM TUBE 120CM 16CH X25

    MDR report key: 4102742 · Received September 12, 2014

    Report

    Report Number
    9611018-2014-00002
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT INDICATES THAT THE PRODUCT WAS USED FOR FEEDING PURPOSES. IN RELATION TO THE FEEDING REFERENCE, THE SALEM SUMP TUBE IS DESIGNED FOR GASTRIC DRAINAGE AS INDICATED IN OUR DECLARATION OF CONFORMITY AND ON OUR LABELING (PVC GASTRODUODENAL TUBE). IN THIS INSTANCE THE PRODUCT HAS BEEN USED OFF LABEL. ADDITIONALLY, THE HOSPITAL INDICATED THAT THE PATIENT HAD A SERIOUS COMPLICATION AFTER THE PATIENT HAD A KANGAROO FEEDING TUBE FOR 14 DAYS. THE PATIENT DIED AND AFTER SUCTION IT APPEARED THAT THE TUBE HAD PERFORATED THROUGH THE STOMACH WALL. AS A RESULT, THE PATIENT HAD PERITONITIS. PRIOR TO THIS THE PATIENT HAD A WHIPPLE OPERATION IN 2012 AND ISCHEMIA FROM THE STOMACH WALL. ACCORDING TO THE DOCTOR THE PATIENT HAD A DIFFERENT ANATOMY OF THE STOMACH. THE REASON THAT THE PATIENT HAD TO GO INTO THE HOSPITAL WAS DUE TO CARDIOGENIC SHOCK. IT WOULD ALSO APPEAR FROM THE ADDITIONAL INFORMATION THAT THERE WERE SEVERE PATIENT COMPLICATIONS PRIOR TO THE INSERTION OF THE TUBE WHICH MAY HAVE CONTRIBUTED TO THE PATIENT DEATH. THE GOAL OF THE WHIPPLE PROCEDURE (ALSO KNOWN AS A PANCREATICODUODENECTOMY) IS TO REMOVE CANCER IN THE HEAD OF THE PANCREAS OR BILE DUCTS. IN THE PROCEDURE, THE SURGICAL ONCOLOGIST WILL REMOVE THE CANCEROUS TISSUE, REMOVE PORTIONS OF THE PANCREAS, BILE DUCT, SMALL INTESTINE AND STOMACH, AND PERFORM IMMEDIATE RECONSTRUCTION.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: SEPTEMBER 11, 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THERE WAS NO PRODUCT LOT NUMBER IDENTIFIED IN THE COMPLAINT REPORT AND THEREFORE WE WERE UNABLE TO COMPLETE A DEVICE HISTORY REVIEW. THERE WAS NO SAMPLE BEING RETURNED FOR THIS COMPLAINT, BUT PHOTOS WERE SUPPLIED WITH THE COMPLAINT INDICATING THE REPORTED CONDITION. BASED ON TRENDING AND THE ABOVE DETAILS, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE RECORDED 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 WHEN USING A FEEDING TUBE. THE CUSTOMER STATES THAT THE PATIENT HAD A SERIOUS COMPLICATION AFTER THE PATIENT HAD A SALEM FEEDING TUBE FOR 14 DAYS. THE PATIENT DIED AND AFTER SUCTION IT APPEARED THAT THE TUBE HAD PERFORATED THROUGH THE STOMACH WALL. AS A RESULT, THE PATIENT HAD PERITONITIS. PRIOR TO THIS INCIDENT, THE PATIENT HAD PERITONITIS. PRIOR TO THIS INCIDENT, THE PATIENT HAD A WIPPEL OPERATION IN 2012 AND ISCHEMIA FROM THE STOMACH WALL. ACCORDING TO THE DOCTOR THE PATIENT HAD A DIFFERENT ANATOMY OF THE STOMACH. THE REASON THAT THE PATIENT HAD TO GO INTO THE HOSPITAL WAS DUE TO CARDIAC GENIC SHOCK. THE INCIDENT OCCURRED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566322 SALEM TUBE 120CM 16CH X25 FEEDING TUBE KNT COVIDIEN 8888264861 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other