BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFTM6.5V-EO PVC FEEDING TUBE PURP 6.5FR 60CM

    MDR report key: 10683234 · Received October 15, 2020

    Report

    Report Number
    3011270181-2020-00120
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 15, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00817584012615
    PMA / PMN Number
    K120182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 15-OCT-2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 NASOGASTRIC (NG) TUBE WAS PLACED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS TAKEN TO EXPLORATORY SURGERY, "BECAUSE HIS BOWELS ARE SHORT AND HE DOESN'T TOLERATE THE FEEDS," AND THEY FOUND A BROKEN PART OF AN NG TUBE IN HIS INTESTINE, THE PHYSICIAN STATED IT, "HAD BEEN IN THERE FOR QUITE A WHILE." THE PATIENT'S FAMILY MEMBER STATED THE PATIENT IS, "DOING FINE," AT PRESENT. ADDITIONALLY, THE FAMILY MEMBER STATED THE PATIENT HAS A TUBE, "IN HIS BELLY, BUT THE NURSE TOLD [ME] THAT HE WOULD HAVE TO HAVE AN NG TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151171 PFTM6.5V-EO PVC FEEDING TUBE PURP 6.5FR 60CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED KNT AVANOS MEDICAL INC. PFTM6.5V-EO UNKNOWN 00817584012615

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO