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

Model Number	40-4438
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 06 apr 2022 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the nasogastric (ng) was confirmed to have broken into two pieces via x-ray.Endoscopy was required to remove a 25cm fragment of tube from the patient.The reporter alleged that it appeared as if some sort of aneurysm rupture occurred causing the tube to break.The patient was receiving medication via the tube four times a day following by a 100ml water flush via the kangaroo pump.The ng tube had been placed on (b)(6) 2022 and had been in use for 13 days prior to the event.Per additional information received on 15 mar 2022, the reporter confirmed that when the tube was initially placed, the tube was flushed with 10ml of water via the side port prior to the stylet being removed.
Additional Manufacturer Narrative
One used sample was returned for evaluation.Per examination, the sample was received in two pieces, broken between the 22 and 21cm depth markings.At the point of the break, the tube exhibits stretching, or ballooning, along with a complete rupture of the tube.Under magnification, no visible occlusion was observed.However, when water was flushed through the distal segment of the device, resistance was felt and no water was able to pass through.Under magnification it was noted that there was completely occlusion from dried matter in the tube.The complaint is confirmed as reported.While no definite root cause could be determined, it was most likely use related.Per the instructions for use, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 28 apr 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 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 CONNECT
• 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: 14046136
• Report Number: 9611594-2022-00036
• Device Sequence Number: 5720982
• Product Code: FPD
• UDI-Device Identifier: 00350770460215
• UDI-Public: 00350770460215
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 40-4438
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• 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: 03/13/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: KANGAROO PUMP
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 50 KG