BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN-UN-CPK-NG TUBE

    MDR report key: 6798334 · Received August 16, 2017

    Report

    Report Number
    3009124963-2017-00040
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    January 28, 2017
    Report Date
    July 25, 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

    NO CODE AVAILABLE-FREE AIR IN ABDOMINAL CAVITY. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 11-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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AN FDA A MEDWATCH REPORT WAS RECEIVED, FDA REPORT NUMBER FDA 3500 FORM 6345046 STATING. EVENT DESCRIPTION: A NASOGASTRIC JEJUNAL TUBE (NGJ) WAS INSERTED IN THE PATIENT IN INTERVENTIONAL RADIOLOGY. THE PATIENT WAS ADMITTED TO THIS FACILITY APPROXIMATELY 10-DAYS AFTER NGJ INSERTION WITH FEEDING INTOLERANCE AND FREE ABDOMINAL AIR NOTED ON THE X-RAY. THE PATIENT SUBSEQUENTLY UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY AND PRIMARY REPAIR OF THE JEJUNAL PERFORATION LOCATED AT THE TIP OF THE NASOGASTRIC JEJUNAL TUBE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578827 UNKNOWN-UN-CPK-NG TUBE DH CPK NG TUBES KNT HALYARD HEALTH UNKNOWN-UN-CPK-NG TUBE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other