BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR-ENDOSCOPIC/RADIOLOGIC

    MDR report key: 9857998 · Received March 19, 2020

    Report

    Report Number
    9611594-2020-00047
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    September 19, 2019
    Report Date
    April 27, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445458
    PMA / PMN Number
    K921370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 24-APR-2020 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 19-MAR-2020 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. 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). MW5092841.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5092841 RECEIVED ON 24-FEB-2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: EVENT INVOLVES PROBLEM WITH MIC-GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTORS-ENDOSCOPIC/RADIOGRAPHIC PLACEMENT. THIS REPORT IS EXAMPLE OF COMPLICATIONS ARISING FROM RISK OF ENFIT PRODUCTS BECOMING STUCK. PT ADMITTED TO THE PICU POST TPIAT WITH A CRITICAL GJ TUBE OVER THE COURSE OF HER ADMISSION IN THE PACU, THE J PORT OF THE GJ TUBE BECAME STUCK IN EFFORTS TO REMOVE, THE J PORT FEMALE ADAPTER WAS DISLODGED AND SUBSEQUENTLY DISCARDED THE INTEGRITY OF THE TUBE WAS COMPROMISED, BUT GIVEN THE CRITICAL NATURE OF THE TUBE AND THE FRESH ABDOMINAL SURGERY, THE PT WAS NOT A CANDIDATE FOR REPLACEMENT AT THAT TIME. CONNECTION BETWEEN THE FEED BAG AND THE J PORT WERE MAINTAINED WITH THE USE OF AN AMT CLAMP. PT TRANSFERRED TO THE FLOOR SEVERAL DAYS LATER. THE AMT CLAMP SYSTEM PROVED TO BE INEFFECTIVE FOR LONG-TERM MANAGEMENT AND NEEDED TO BE REPLACED MULTIPLE TIMES. EVENTUALLY, THE J PORT RIPPED, MAKING IT IMPOSSIBLE TO SECURE THE FEEDING BAG CONNECTION, RESULTING IN THE LOSS OF ENTERAL PRODUCTS. THIS LED TO SEVERE HYPOGLYCEMIA AND THE PT NEEDED AN ADD'L ANESTHESIS OPERATING ROOM CASE FOR GJ TUBE REPLACEMENT. DURING THE CASE, THE PT DEVELOPED HYPOXEMIA AND SUBSEQUENTLY ARDS REQUIRING PROLONGED INTUBATION AND ADD'L CARE DAYS IN THE PICU, FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321051 MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR-ENDOSCOPIC/RADIOLOGIC DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8250-18 UNKNOWN 00350770445458

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention