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

Model Number 40-5431

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).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.Root cause could not be determined.All information reasonably known as of 22 dec 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 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.Device not returned.

Event Description

It was reported, the patient was found with a cortrak stylet in a weighted corflo tube, the stylet was beyond the exit port; the patient died.Additional information received 30nov2022 reported, the patient (pt) was admitted to the hospital and was awaiting a liver transplant.The corflo weighted tube was placed blindly by the admitting physician, (placement date unknown).On (b)(6) 2022 the (pt), housed on med-surg floor, was seen by an on-call partner physician who noted a change in status with increased ascites; the patient was transferred to the intensive care unit (icu).The icu nurse observed the stylet in the nasogastric tube (ngt) and attempted to remove it but was unsuccessful; therefore, the ng tube and stylet were removed together.It was noted that the end of a cortrak transmitting stylet was protruding from the exit port of the weighted non-stylet corflo ngt; a new cortrak feeding tube was placed post-pyloric without incident using cortrak eas.As part of the liver transplant work-up, the patient went to endoscopy (date unknown) for a liver transplant work-up; the patient was returned to the icu and was reported to be unstable and required code blue intervention more than once.The patient passed away.The nurse reported, at the time there did not appear to be a correlation between the stylet in the corflo tube and the patient¿s outcome.

Manufacturer Narrative

All information reasonably known as of 09 feb 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 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.

Manufacturer Narrative

H6: (appropriate term/code not available): investigation findings: usage problem identified the actual sample from the reported event was not returned for evaluation; however, the customer provided images of the alleged device, from which the stock code and the reported incident were confirmed.Based on the complaint description and images provided, the stylet used in the reported corflo feeding tube incident was determined to be a cortrak transmitting stylet.Instructions for use (ifu) for both the corflo ng/ni feeding tubes and cortrak feeding tubes have specific warnings about not using a stylet that does not come packaged with the feeding tube, as well as not inserting a stylet into the tube while the tube is in the patient.All corflo and cortrak feeding tubes are matched with their stylet 1:1 during the manufacturing process for length.And to eliminate the possibility of mix-up during manufacturing, corflo and cortrak feeding tubes and stylets are manufactured separately.Additionally, package warnings clearly state, ¿only qualified clinicians trained according to avanos cortrak 2 training procedures should use the cortrak 2 as an aid in the placement of compatible avanos cortrak 2 feeding tubes¿.Other risk control measures include, labeling on the side of the feeding tube, with the brand.Based on the manufacturing process, labeling of the tubes, and warnings in both ifus against using stylets not packaged with the feeding tube; the root cause was determined to be user: incorrect use.All information reasonably known as of 28 mar 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 complaint database and identified as complaint comp-ghc-22-04538.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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL TUBE W/ ENFIT
• 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
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16039812
• MDR Text Key: 306044396
• Report Number: 9611594-2022-00158
• Device Sequence Number: 1
• Product Code: KNT
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-5431
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/09/2023; 03/04/2023
• Supplement Dates FDA Received: 02/13/2023; 03/29/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Sex: Male