BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC* GASTROSTOMY FEEDING TUBE - 20 FR

    MDR report key: 6802031 · Received August 17, 2017

    Report

    Report Number
    9611594-2017-00121
    Event Type
    Death
    Date Received
    August 17, 2017
    Date of Event
    March 25, 2017
    Report Date
    August 17, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10680651948219
    PMA / PMN Number
    K842076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 29-AUG-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 15 AUG 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED 17 AUG 2017, THE HOSPITAL PHARMACIST COULD NOT CONFIRM THE HOSPITAL'S PRACTICES DUE TO HOW MUCH TIME HAD PASSED SINCE THE REPORTED EVENT. THE PHARMACIST ALSO REPORTED THAT "THE ENTERAL FEEDING ON GASTROSTOMY BEGAN AFTER THE TUBE WAS PLACED. THE PATIENT NEVER HAD A FEEDING TUBE BEFORE. THE PATIENT LOST (B)(6) OVER 6 MONTHS WITH PROGRESSIVE DYSPHAGIA IN A CARCINOMA OF THE MIDDLE ESOPHAGUS. THE DEVICE WAS PLACED AT LEFT HYPOCHONDRIUM. THE PATIENT HAD A MEDIAN LAPAROTOMY. THERE IS A RELEASE OF THE GASTROSTOMY WHOSE BALLOON IS NOT INFLATED." 7 ML OF FLUID WAS REMOVED FROM THE BALLOON PRIOR TO REMOVAL, AND NO DEFECT WAS REPORTED REGARDING THE TUBE OR THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED ON (B)(6) 2017, WITH 7 ML STERILE WATER USED TO FILL THE BALLOON. THERE WAS NO PATIENT INFECTION DETECTED BEFORE THE DEVICE WAS PLACED. ON (B)(6) 2017, PERITONITIS WAS DETECTED. A SURGERY WAS PERFORMED, AND THE PATIENT DIED. PER ADDITIONAL INFORMATION RECEIVED 2017-08-03 FROM THE DISTRIBUTOR ((B)(4)), THEY HAVE RECEIVED INFORMATION ORALLY FROM THE HOSPITAL WHICH INDICATED THAT THE HOSPITAL HAS RULED OUT THE RELATIONSHIP OF THE DEVICE WITH THE PERITONITIS AND THE PATIENT'S DEATH. ADDITIONALLY, ASEPT INMED PERSONNEL VISITED THE HEALTHCARE INSTITUTION AND OBTAINED CONFIRMATION FROM THE HOSPITAL THAT THE EVENT WAS RELATED TO THE HOSPITAL'S PRACTICES ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580533 MIC* GASTROSTOMY FEEDING TUBE - 20 FR DH EF BALLOON TUBES PRODUCTS KNT HALYARD HEALTH 0112-20 UNKNOWN 10680651948219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death