BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NG TUBE/NASOINTESTINAL FEEDING TUBE WITH STYLET

    MDR report key: 16164715 · Received January 13, 2023

    Report

    Report Number
    9611594-2023-00113
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 9, 2022
    Report Date
    March 9, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770457550
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 13-JAN-2022 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 · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30192340, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2023 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 (B)(4), 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 · 0

    IT WAS REPORTED VIA FDA FDA USER FACILITY REPORT # MW5113771 THE FOLLOWING INFORMATION: "SMALL BORE FEEDING TUBE FRACTURE." ADDITIONAL INFORMATION RECEIVED 21-DEC-2022 STATED THE NASOGASTRIC TUBE (NG) TUBE WAS NOTED TO BE MALPOSITIONED. WHEN REMOVED, THE WEIGHTED TIP WAS RETAINED IN THE PATIENT. THE PATIENT REQUIRED ENDOTRACHEAL TUBE EXCHANGE AND A BRONCHOSCOPY FOR FOREIGN BODY REMOVAL. THE NG TUBE WAS IN PLACE 'LESS THAN 30 MINUTES, LIKELY EVEN LESS' PRIOR TO THE FRACTURE OCCURRING. THE NG TUBE WAS NOT FLUSHED WITH 10 CC OF WATER AFTER PLACEMENT WAS CONFIRMED, AND NOT FLUSHED PRIOR TO THE REMOVAL OF THE STYLET TO ACTIVE THE INTERNAL LUBRICANT OF THE NG TUBE. THE NG TUBE WAS IMMEDIATELY NOTED TO BE MALPOSITIONED AND THUS THE STYLET WAS NEVER REMOVED, NOR WAS ANYTHING USED TO FLUSH THE NG TUBE. THE FRACTURE APPEARS WHERE THE WEIGHTED TIP MEETS THE REST OF THE TUBE/STYLET. THERE WAS NO INDICATION THE NG TUBE WAS CLOGGED BECAUSE IT WAS NEVER USED. THE WEIGHTED NG TUBE TIP WAS LEFT INSIDE THE PATIENT¿S BODY. THE PATIENT WAS INTUBATED FOLLOWING CEREBRAL EDEMA FROM A SUBOCCIPITAL CRANIOTOMY FOR TUMOR DEBULKING. THE NG TUBE WAS PLACED PRIOR TO EXTUBATION OF THE ENDOTRACHEAL TUBE TO HELP FACILITATE CONTINUED ENTERAL NUTRITION. MALPOSITION OF THE NG TUBE WAS NOTED, AND THE NG TUBE WAS REMOVED AND UNFORTUNATELY THE DISTAL WEIGHTED TIP WAS RETAINED INSIDE OF THE PATIENT. THE PATIENT NEEDED AN ENDOTRACHEAL TUBE EXCHANGE, AND A BRONCHOSCOPY WAS PERFORMED FOR FOREIGN BODY REMOVAL. AT NO POINT IN TIME ¿ INSERTION OR REMOVAL ¿ WAS THERE ANY RESISTANCE FELT ON THE NG TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464989 CORFLO NG TUBE/NASOINTESTINAL FEEDING TUBE WITH STYLET DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-7368 30192340 00350770457550

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| O