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

Model Number	42-9226
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.Photos of the device were provided by the customer.All information reasonably known as of 09 sep 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.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).
Event or Problem Description
It was reported that the nasojejunal tube was removed by a nurse as the infant had reached full feeds and no longer required the tube.Upon removal, the tube was found to stop at the 12cm mark.The tube appeared "distended/stretched like an aneurysm" and was broken at this point.X-ray confirmed the remained of the tube was in the patient's proximal small bowel.At the time of the report, no medical intervention had been performed.Device was in use for 36 days.Patient is not reported to be injured, but does "remain in high dependence on neonatal intensive care unit." additional information has been requested but not yet received.
Additional Manufacturer Narrative
Photos of the device were provided by the customer.The reported event was confirmed via review of the photos; however, root cause could not be determined.All information reasonably known as of 23 oct 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.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
All information reasonably known as of 05 oct 2020has 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.
Event or Problem Description
Additional information received 17-sep-2020 indicated intervention was required to remove the broken tube.No further information was provided regarding the patient's condition.Additional information received 22-sep-2020 indicated the distal end of the tube was retrieved from the infant surgically on (b)(6) 2020.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10513617
• Report Number: 9611594-2020-00170
• Device Sequence Number: 2445323
• Product Code: KNT
• UDI-Device Identifier: 00350770460864
• UDI-Public: 00350770460864
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-9226
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/07/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/06/2020; 10/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 6 MO
• Patient Weight: 4