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

Model Number	40-1366
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.The device was evaluated.The sample evaluation revealed that resistance was felt while flushing and a brownish substance was flushed out of the tube; additionally the distal side was also flushed through and a sticky/ slimy pink substance came out of the bolus tip.The reported event could not be confirmed as reported however; this seems to be a user related problem, since the instructions for use (ifu), state that vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.The device history record for lot 30161252 was reviewed and the product was produced according to product specifications.All information reasonably known as of 24 feb 2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
It was reported that the patient had a 6 french nasogastric tube that had been repositioned/used in an upper gi study to evaluate feeding intolerance, prior to the study the tube was post-pyloric; the tube was pulled back into the stomach for a gastrointestinal study.Following the study [the tube] was advanced post-pyloric again for feeding as [the] patient was not tolerating gastric feeds due to frequent emesis, xray verification [was performed] at all steps.It was noted that the patient had emesis overnight, an xray showed the tube was coiled in the stomach with the tip still post-pyloric.The feeding tube was pulled back to keep the tip post-pyloric and to alleviate the coiling.Upon pulling the tube back, it was noted that the feeding tube was cracked and almost separated into two pieces.It was reported that the patient was likely being fed gastric for several days resulting in excessive emesis.The tube was removed and a new feeding tube placed.No additional information was provided concerning the patient¿s condition or whether medical intervention was required.The device was placed on (b)(6) 2022 and removed on (b)(6) 2022.Additional information received, 31jan2022 reported that the tube was in place for approximately eight days and it was used for infant formula and oral suspension medications.It was noted, by the healthcare professional that the tube was not clogged and the method the healthcare professional used to de-clog the tube was provided: (enzymatic clog removal solution, syringe solution w/force).The patient did not have any additional adverse events, other than the frequent emesis and there was no report of additional medical intervention beyond replacing the device; the patient remained in the intensive care unit (icu) and was said to be working on feeding and growing.Additionally, an fda user facility report #(b)(4) was received on 10feb2022.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13594330
• Report Number: 9611594-2022-00021
• Device Sequence Number: 14434925
• Product Code: FPD
• UDI-Device Identifier: 00350770459981
• UDI-Public: 00350770459981
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: 40-1366
• Device Catalogue Number: N/A
• Device Lot Number: 30161252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 5 KG