BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENFIT PVC FEEDING TUBE ORANGE 6.5FR 60CM

    MDR report key: 10320053 · Received July 24, 2020

    Report

    Report Number
    3011270181-2020-00106
    Event Type
    Death
    Date Received
    July 24, 2020
    Report Date
    September 28, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00817584011434
    PMA / PMN Number
    K120182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 22 JUL 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT 20170730 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 18 SEP 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT CODES: PULMONARY HYPERTENSION, CARDIORESPIRATORY FAILURE. ALL INFORMATION REASONABLY KNOWN AS OF 19 AUG 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 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.

    Description of Event or Problem · 1

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2020-00104 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00105 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS AN ESOPHAGEAL PERFORATION BY THE FEEDING TUBE DURING PLACEMENT. THE TUBE WAS BEING PLACED TO HELP VENT THE STOMACH FOR AN INFANT REQUIRING RESPIRATORY SUPPORT. THE PERFORATION WAS NOTED IMMEDIATELY ON ADMISSION FOLLOWING PLACEMENT OF THE TUBE. NO FURTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED 30 JUL 2020, PATIENT WAS BORN PRE-TERM WITH GESTATIONAL AGE (B)(6) AND WEIGHED (B)(6). THE PATIENT WAS INTUBATED AT BIRTH AND A FEEDING TUBE PLACED. DURING INSERTION OF THE FEEDING TUBE, RESISTANCE WAS FELT AT 10CM. CHEST X-RAY SHOWED THAT THE TUBE OVERLAID THE LOW THORACIC ESOPHAGUS. THE TUBE WAS REMOVED AND A RIGHT PNEUMOTHORAX WAS NOTED ON A CHEST X-RAY PERFORMED 30 MINUTES LATER. ORDER WAS MADE FOR PATIENT TO RECEIVE NO FOOD BY MOUTH OR FEEDING TUBE, THE PATIENT WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS DUE TO THE PRE-TERM LABOR. ESOPHAGEAL PERFORATION WAS SUSPECTED BUT NOT CONFIRMED. ANOTHER FEEDING TUBE WAS PLACED WHEN THE PATIENT WAS 6 DAYS OLD, NO COMPLICATIONS AND POSITION WAS CONFIRMED BY CHEST X-RAY. DURING THE HOSPITAL COURSE, PATIENT ALSO DEVELOPED PULMONARY HYPERTENSION, RESPIRATORY FAILURE, SEPSIS, HYPOTENSION, ANEMIA AND SEVERE INTRAVENTRICULAR HEMORRHAGE. PATIENT WAS WITHDRAWN FROM SUPPORT ON DAY OF LIFE 9 DUE TO CARDIORESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788196 ENFIT PVC FEEDING TUBE ORANGE 6.5FR 60CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) KNT AVANOS MEDICAL INC. FTM6.5V-NC 20170730 00817584011434

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death| R