MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR; DH CPK NG TUBES

Model Number 40-9366

Device Problems Break (1069); Material Separation (1562); Obstruction of Flow (2423)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

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 16 apr 2024 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 reported event but is relaying the information 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.

Event Description

It was reported via fda medwatch/ user facility report mw report (b)(4), ¿patient had end of nasogastric (ng) tube break off in stomach and is waiting to pass small piece of ng tube through stool.Per report, about a week ago, patient had clog in ng tube, after registered nurse (rn) flushed tube, chest x-ray was done (due to chest tube) and small end part of ng tube was found to be broken away from ng tube and in patient's stomach.Gastroenterologist (gi) consulted and expects ng tube fragment to pass.Ng tube was removed and replaced.Subsequent x-rays and kidney, ureter, and bladder (kub) has shown part of ng tube now in transverse colon.We are waiting to ng tube to be excreted in stool, checking each stool for ng tube.No complaints per patient.Primary hematology oncology (heme/onc) team aware, charge rn and unit educator.Investigated with nurse staff and found that there were no issues with ng insertion.Ng tube had been placed, no indications when placing the ng tube that it was defective.This finding was an incidental finding when doing a chest x-ray for another purpose.Abdominal x-ray confirmed passing of ngt fragment.¿ per additional information received 02-apr-2024, the ngt was initially placed on (b)(6) 2023.Crushed medications were administered through the tube.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19130274
• MDR Text Key: 341463314
• Report Number: 9611594-2024-00060
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460420
• UDI-Public: 00350770460420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9366
• Device Catalogue Number: N/A
• Device Lot Number: 30255814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 MO
• Patient Sex: Male