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

Model Number	40-9551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Swollen Lymph Nodes/Glands (4432); Skin Inflammation/ Irritation (4545)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 20 nov 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.
Event or Problem Description
It was reported, the home-care registered dietitian (rd) spoke to the patient who stated, they had previously needed a gastrostomy-jejunostomy tube (gj-tube) and experienced stomach contents leaking onto their skin; a wound started to form.No additional information was provided concerning this report, including the brand of the tube and if any medical attention was provided.It was additionally reported, the [current] nasogastric tube was placed on (b)(6) 2022 and the patient began the peptide based formula.The first reported allergic reaction was on (b)(6) 2022, the formula was then changed to an elemental formula.On (b)(6) 2022, the patient reported a continued allergic reaction, and the formula was changed again, to a different elemental formula.[as a result], the patient was trialed on 3 different formulas (peptide based, elemental and a second elemental from a different manufacturer); all with the same ¿allergic symptoms¿; there was no reported problem(s) with increasing the feeding formula to goal rate.The patient reported, they used silicone tape to adhere the tube to their cheek and tucked it over their ear, the tape was in place for a day; after the tape was removed, they discovered an itchy red stripe (not from where the tape had touched their face).The tube was then moved and draped ¿on the left side¿ and taped with silicone tape, it was there for two days; when the tube and tape were removed the rash was noted to be ¿bigger and itchier¿.The patient additionally reported irritation on the tops of their ears, itching of the ears and itching and swelling of the throat, which was initially swollen ¿for several days¿.The patient has been using benadryl and the prescription atarax for over a week and reported that the throat swelling has gone down; however, they continue to experience itching in their throat and ears which is being managed, ¿ok¿ by the medications and was noted to be ¿a bit better¿.The patient has since begun to clip the tube to their shirt using a ¿blow-drying clip¿ and stated that since they began doing so, the red ¿stripes¿ on their cheeks were slowly getting better.The rd also provided alternative methods for securing the tubing away from the skin; the patient¿s current condition was not reported.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET
• 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: 15846249
• Report Number: 9611594-2022-00142
• Device Sequence Number: 17603620
• Product Code: KNT
• UDI-Device Identifier: 00350770460529
• UDI-Public: 00350770460529
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 40-9551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENDRYLATARAX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 85 KG