BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE, 22 FR

    MDR report key: 7895209 · Received September 20, 2018

    Report

    Report Number
    9611594-2018-03640
    Event Type
    Injury
    Date Received
    September 20, 2018
    Report Date
    October 26, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651947823
    PMA / PMN Number
    K842076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 20-NOV-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).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 19-SEP-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. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORT (B)(4) WAS RECEIVED THAT STATED: PATIENT UNDERWENT A SURGICAL PROCEDURE EARLIER THIS MONTH TO PLACE A GASTROSTOMY TUBE. BALLOON ON DEVICE WAS SUCCESSFULLY TESTED PRIOR TO INSERTING INTO PATIENT. THE DEVICE WAS INSERTED BY THE SURGEON AND THE BALLOON WAS INFLATED ONCE IN THE PATIENT AND WAS NOTED TO BE SUCCESSFULLY INFLATED. PATIENT BECAME UNSTABLE OVERNIGHT AND HAD A CT PULMONARY ANGIOGRAPHY (CTPA) IN THE MORNING THE NEXT DAY. PATIENT HAD A PULMONARY EMBOLUS AND ALSO NOTED TO HAVE A LARGE AMOUNT OF INTRAPERITONEAL FREE AIR. THE PATIENT WAS TAKEN QUICKLY BACK TO THE QR TO ASSESS THE ABDOMEN. WHEN THE PATIENT WAS TRANSFERRED OFF THE BED, THE GASTRONOMY TUBE FELL OUT OF THE PATIENT AND THE BALLOON WAS DEFLATED. THE PATIENT WAS NOTED TO HAVE TUBE FEEDING IN THE ABDOMEN. THE PATIENT REQUIRED AN ICU ADMISSION FOLLOWING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736412 MIC GASTROSTOMY FEEDING TUBE, 22 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0100-22 AA8071D10 10680651947823

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR