BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENTERAL FEEDING TUBE

    MDR report key: 10398774 · Received August 12, 2020

    Report

    Report Number
    9611594-2020-00138
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 12, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION OF THE POTENTIAL DEFECT; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED AND CONFIRMED THE REPORTED INCIDENT. A ROOT CAUSE WAS NOT IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE G-PORTION OF THE GASTROSTOMY-JEJUNOSTOMY TUBE BROKE OFF FROM THE FEEDING TUBE AND WAS STILL CONNECTED TO THE EXTENSION SET. THE PATIENT'S STOMACH CONTENTS LEAKED, AND THE SKIN WAS RED AND IRRITATED. THE IRRITATED SKIN WAS TREATED WITH CREAM. THE TUBE HAD BEEN IN PLACE FOR 6-MONTHS PRIOR TO THE INCIDENT. THE PATIENT'S FAMILY MEMBER STATED THIS MORNING, "I GAVE HER MEDS[MEDICATIONS] AND TRIED TO UNHOOK HER IT ALL FELL APART. STOMACH ACID SPEWED ALL OVER HER STOMACH AND NOW IT¿S RED, BUT WE HAVE MEDICINE FOR THAT." ADDITIONAL INFORMATION RECEIVED 21-JUL-2020 STATED THAT FOR SKIN TREATMENT, "WE HAVE PRESCRIPTION AND ALSO BURT¿S BEES ALMOND MILK HAND CREAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861808 UNKNOWN ENTERAL FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other