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

Model Number	20-7368
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via fda fda user facility report # mw5113771 the following information: "small bore feeding tube fracture." additional information received 21-dec-2022 stated the nasogastric tube (ng) tube was noted to be malpositioned.When removed, the weighted tip was retained in the patient.The patient required endotracheal tube exchange and a bronchoscopy for foreign body removal.The ng tube was in place 'less than 30 minutes, likely even less' prior to the fracture occurring.The ng tube was not flushed with 10 cc of water after placement was confirmed, and not flushed prior to the removal of the stylet to active the internal lubricant of the ng tube.The ng tube was immediately noted to be malpositioned and thus the stylet was never removed, nor was anything used to flush the ng tube.The fracture appears where the weighted tip meets the rest of the tube/stylet.There was no indication the ng tube was clogged because it was never used.The weighted ng tube tip was left inside the patient¿s body.The patient was intubated following cerebral edema from a suboccipital craniotomy for tumor debulking.The ng tube was placed prior to extubation of the endotracheal tube to help facilitate continued enteral nutrition.Malposition of the ng tube was noted, and the ng tube was removed and unfortunately the distal weighted tip was retained inside of the patient.The patient needed an endotracheal tube exchange, and a bronchoscopy was performed for foreign body removal.At no point in time ¿ insertion or removal ¿ was there any resistance felt on the ng tube.
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 13-jan-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, 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30192340, 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 (b)(6) 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, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(4), 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 TUBE/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
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16164715
• Report Number: 9611594-2023-00113
• Device Sequence Number: 20577304
• Product Code: KNT
• UDI-Device Identifier: 00350770457550
• UDI-Public: 00350770457550
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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?: No
• Device Model Number: 20-7368
• Device Catalogue Number: N/A
• Device Lot Number: 30192340
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male