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

Model Number	40-7368
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Obstruction of Flow (2423); Malposition of Device (2616); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 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 comp (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.
Event or Problem Description
It was reported, "nasogastric tube insertion in a 3-year-old child.The procedure went well, and a weighted, guided ch8 tube was quickly inserted.When trying to remove the guide with a catheter in place, it was impossible to pull it out, so we tried several times before finally giving in and pulling it out with force.When it came time to inject air to listen to the correct positioning of the probe in the stomach, it was impossible to inject anything.Even getting the child to drink didn't help.X-ray check ordered, showing an angled probe that went down into the oesophagus but came up in the middle of the oesophagus.The tube was subsequently removed and a new one inserted.Per additional information received on 12feb2024, ¿the nasogastric tube was not flushed with 10 ml of water before removal of the stylet/guidewire.We've already made the customer aware of the importance of flushed the tube with 10 ml of water before removal of the stylet/guidewire.¿.
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 26 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 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.
Additional Manufacturer Narrative
Additional information: d4, h4, h6.The device history record for lot 30229979 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.A complaint regarding "impossible to pull the guide" was examined prior to decontamination and soaking of component.Following the instructions for use (ifu), the lumen was irrigated with water until the water was visible at the distal end of the tubing.Once the irrigation was complete, the stylet was removed with no resistance.After decontamination, the stylet guidewire was examined.Approximately 2 inches from the tip of stylet guidewire (proximal side) the purple hub was seen detached.Bent/ kinked markings were evident on the guidewire proximal end as well.At the middle portion of the stylet guidewire, curvature, slight bending was also seen.The root cause was determined to be incorrect use.All information reasonably known as of 06 jan 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 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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18825062
• Report Number: 9611594-2024-00025
• Device Sequence Number: 7879319
• Product Code: KNT
• UDI-Device Identifier: 00350770460314
• UDI-Public: (01)00350770460314(240)104603102(17)271106(10)30229979
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

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: 40-7368
• Device Catalogue Number: N/A
• Device Lot Number: 30229979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 12/11/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/28/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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
• Patient Age: 3 YR
• Patient Sex: Female