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

Model Number	40-7361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the reported lot number, 30113496, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 13-may-2021 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, inc.Complaint database and identified as complaint (b)(4).The device was not returned.
Event or Problem Description
It was reported the patient with a feeding tube presented to the emergency room (er) with complaints of pain in her chest when attempting to use her nasogastric (ng) tube placed on 28-mar-2021.The patient stated her ng tube will not flush, "it appeared clogged".Upon x-ray, ng tube appeared to be in 2 pieces in her esophagus.Ng tube had to be removed in the operating room.The ng tube was still intact; however, there appeared to be "an area that looked like it had ballooned and only a thin sheath keeping the ng tube together." the patient did not have another ng tube placed.The patient was discharged home from the recovery room in stable condition.X-ray of incident requested.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.All information reasonably known as of 17-jun-2021 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNEC
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11828577
• Report Number: 9611594-2021-00071
• Device Sequence Number: 17201038
• Product Code: FPD
• UDI-Device Identifier: 00350770460291
• UDI-Public: 00350770460291
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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 Expiration Date: 02/10/2026
• Device Model Number: 40-7361
• Device Catalogue Number: N/A
• Device Lot Number: 30113496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Weight: 57