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

Model Number	42-7366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2020
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 not possible as no lot number was provided.All information reasonably known as of 21 feb 2020 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.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).
Event or Problem Description
It was reported that a nasogastric (ng) tube was inserted into an infant patient diagnosed with food intolerance and gastro-oesophageal reflux.The tube was inserted to 20cm and placement was confirmed via acidic aspirate.Overnight the tube advanced by 2cm, three times.An x-ray on (b)(6) 2020 confirmed that the tube had broken in the patient's stomach.Patient has family history pyloric stenosis.This was confirmed in the patient via ultrasound.Broken piece was retrieved at the time of the pyloromyotomy via small gastrostomy.Per additional information received 11 feb 2020, the patient had been scheduled to have a pyloromyotomy anyway, and an additional small procedure (gastrostomy) was performed to remove the broken piece of ng tube.The patient has since fully recovered from the operation.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9751890
• Report Number: 9611594-2020-00032
• Device Sequence Number: 14235489
• Product Code: KNT
• UDI-Device Identifier: 20815149020574
• UDI-Public: 20815149020574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 42-7366
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 3