MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI FEED TUBE, STYLET, ENFIT; DH CPK NG TUBES

Model Number	40-9438
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via fda user report (b)(4) the following information: patient with new onset tachycardia up to 180-190s while calm, occasionally into the 200's (max heart rate 210), who initiated the rrt (rapid response team).Background: 22 months-old male admitted with respiratory syncytial (rsv) bronchiolitis and eat (ectopic atrial tachycardia).Nasojejunal tube (nj) in place for meds and feeds.Assessment: patient baseline hr 110's-120's while in pediatric intensive care unit (picu) and initially during first 10-15 on unit, abrupt increase with persistent hr > 180.Patient also on enteral feeds where nj was noted to be taped due to broken/loose connection and upon assessment was leaking feeds and likely medication.Last documented dose of sotalol was [time redacted] in picu prior to patient transferring to pcu 300.This dose of sotalol likely never reached the patient due to malfunctioning tube, leading to ectopic atrial tachycardia (eat).Registered respiratory therapist (rrt) called within 5 minutes of rsn being called to room by bedside rn and rsn identifying eat.Requested a stat ekg and ivf.Recommendation: transfer to icu to resolve eat with either iv medication or placement of new njt and nj sotalol administration.After review with the bedside, rn learned the side port of the nj tube had tape on it.Once medication administered on pcu 300 noted viscosity of medication and if this contributed to the tube side port disintegrating.
Additional 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 11-mar-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 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.H3 other text : device not returned.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30274486, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 06-aug-2025 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, 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.

• Brand Name: CORFLO NG/NI FEED TUBE, STYLET, ENFIT
• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18887798
• Report Number: 9611594-2024-00036
• Device Sequence Number: 11525960
• Product Code: KNT
• UDI-Device Identifier: 10350770460502
• UDI-Public: (01)10350770460502(240)104605002(17)280813(10)30274486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: Health Professional
• Device Model Number: 40-9438
• Device Catalogue Number: N/A
• Device Lot Number: 30274486
• Was Device Available for Evaluation?: No
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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: SOTALOL.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 MO
• Patient Sex: Male