BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HALYARD GASTRIC-JEJUNAL TUBE

    MDR report key: 7133723 · Received December 20, 2017

    Report

    Report Number
    9611594-2017-00169
    Event Type
    Death
    Date Received
    December 20, 2017
    Report Date
    November 30, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 18 DEC 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A STUDY THAT SEVEN PATIENTS EXPERIENCED PERFORATIONS DURING PLACEMENT OF GASTRIC-JEJUNAL TUBES. THESE PATIENTS HAD AN AVERAGE WEIGHT OF 4.6 KG (RANGE 3.0¿11.2 KG) WITH A MEDIAN AGE OF 17 WEEKS (RANGE 8 WEEKS¿2.1 YEARS). THERE WERE TWO TYPES OF FEEDING TUBES INVOLVED IN THE STUDY, ONE OF WHICH WAS MANUFACTURED BY HALYARD, AND THE OTHER MANUFACTURED BY APPLIED MEDICAL TECHNOLOGY, INC. IT IS UNKNOWN WHICH, IF ANY, OF THE REPORTED EVENTS INVOLVED HALYARD DEVICES. THE PERFORATION WAS DIAGNOSED EARLY IN THREE PATIENTS, EITHER IN THE OPERATING ROOM OR IMMEDIATELY POST-OPERATIVELY, VIA FREE AIR VISIBLE ON POST-PLACEMENT X-RAY. THESE PATIENTS WERE TREATED WITH AN IMMEDIATE LAPARATOMY. FOR THE OTHER FOUR PATIENTS, DELAYED PERFORATION WAS DIAGNOSED WITH CLINICAL DECOMPENSATION LEADING TO LAPARATOMY. ONE OF THE PATIENTS DIED FROM SUBSEQUENT SEPSIS. ALL CASES OF PERFORATION OCCURRED NEAR THE LIGAMENT OF TREITZ AT THE LOCATION OF THE TIP OF THE JEJUNAL EXTENSION OF THE GASTRIC-JEJUNAL TUBE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915160 UNKNOWN HALYARD GASTRIC-JEJUNAL TUBE DH EF BALLOON TUBES PRODUCTS KNT HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R