BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORPAK TUBE

    MDR report key: 24818199 · Received April 8, 2026

    Report

    Report Number
    9611594-2026-00181
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 7, 2026
    Report Date
    May 22, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 07-APR-2026 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 (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE BEDSIDE NURSE REPORTED THAT THERE HAD BEEN SOME DIFFICULTY FLUSHING THE TUBE...THOUGH IT REMAINED FUNCTIONAL. LATER, THE FLUSHING BECAME EASIER. ON THE MORNING X-RAY, THERE WAS CONCERN THAT THE TUBE HAD BROKEN. THE [ADVANCED PRACTICE PROVIDER] APP REMOVED IT, BUT ONLY APPROXIMATELY 45CM CAME OUT. THE PATIENT ULTIMATELY REQUIRED INTUBATION AND AN [ESOPHAGOGASTRODUODENOSCOPY] EGD, DURING WHICH THE REMAINING 50CM OF TUBING WAS RETRIEVED. ADDITIONAL INFORMATION RECEIVED (B)(6)2026 STATING THE NASOGASTRIC TUBE PLACEMENT WAS INSERTED UNDER FLUOROSCOPY. PER THE PROCEDURE NOTES THERE WAS INDICATION OF DIFFICULTY DURING PLACEMENT THE DEVICE WAS USED FOR CONTINUOUS TUBE FEEDING. THE PATIENT FEEDING SOLUTION CONSISTED OF NOVASOURCE RENAL. ORAL AND CRUSHED MEDICATIONS WERE INFUSED THROUGH THE DEVICE. THE DEVICE WAS FLUSHED EVERY 4-HOURS. THE DEVICE WAS FLUSHED MANUALLY WITH A 60ML SYRINGE. TO UNCLOG THE DEVICE THE CLINICIANS USED CLOGZAPPER USED ON 0(B)(6) 2026. ULTIMATELY THE PATIENT HAD TO BE REINTUBATED AND EGD PERFORMED TO REMOVE REMAINING TUBE. THERE WAS NO ADVERSE EVENTS OTHER THAN THE NECESSARY INTERVENTIONS TAKEN TO REMOVE REMAINING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312861 UNKNOWN CORPAK TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1