BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAF-T-PEXY* T-FASTENERS

    MDR report key: 6803598 · Received August 18, 2017

    Report

    Report Number
    9611594-2017-00118
    Event Type
    Death
    Date Received
    August 18, 2017
    Date of Event
    June 29, 2017
    Report Date
    December 1, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    UDI-DI
    10680651987010
    PMA / PMN Number
    K093312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16AUG2017 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 DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER, AA7086R01, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE T-TACKS SEPARATED WHILE THE PATIENT WAS ON THE FLOOR. THE GASTROSTOMY-TUBE WAS RE-POSITIONED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JUL-2017 STATES THAT THE TUBE WAS PLACED IN THE PATIENT ON (B)(6) 2017. THE PATIENT EXPIRED ON PALLIATIVE CARE (B)(6) 2017. THE CO-MORBIDITIES INCLUDED INTRACRANIAL BLEED (ADMITTING DIAGNOSIS) AND A HISTORY OF LUNG AND PROSTATE CANCER, UNCONTROLLED HYPERTENSION, DYSPHAGIA, ASPIRATION AND A URINARY TRACT INFECTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585311 SAF-T-PEXY* T-FASTENERS DIGESTHEALTH ENTERAL FEED PERC PLACEMENT KGC HALYARD HEALTH 98701 AA7086R01 10680651987010

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death