BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    MDR report key: 8011260 · Received October 28, 2018

    Report

    Report Number
    9611594-2018-00198
    Event Type
    Injury
    Date Received
    October 28, 2018
    Report Date
    October 4, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2018-00195 FOR THE FIRST EVENT. REFER TO 9611594-2018-00196 FOR THE SECOND EVENT. REFER TO 9611594-2018-00197 FOR THE THIRD EVENT. A CLINICAL STUDY WAS RECEIVED FROM (B)(6) STATING: JOURNAL OF SURGICAL RESEARCH 199 (2015) 67-71. ASSOCIATION FOR ACADEMIC SURGERY: COMPLICATIONS OF GASTROJEJUNAL FEEDING TUBES IN CHILDREN IN THE COURSE OF THE STUDY, IT WAS DETERMINED THAT A PATIENT REQUIRED EMERGENT LAPAROTOMY FOR INTESTINAL PERFORATION DUE TO GJ TUBE PLACEMENT. JEJUNAL OBSTRUCTION WITH HEMATOMA AND CONTAINED PERFORATION AT THE OF TIP OF GJ TUBE. THERE WAS NO DEATH ASSOCIATED WITH THIS INCIDENT. NO FURTHER DETAILS ABOUT THE OUTCOME FOR THE PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852896 UNKNOWN GASTROJEJUNAL FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other