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

Model Number 42-7361

Device Problems Material Rupture (1546); Obstruction of Flow (2423)

Patient Problems Pain (1994); Bowel Perforation (2668); Foreign Body In Patient (2687)

Event Date 10/12/2023

Event Type  malfunction  

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 dec 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 reported event but is relaying the information 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.H3 other text : device not returned.

Event Description

It was reported, nasogastric tube (ngt) was blocked.It was in use for six weeks.There was no dead space in feeding tube for unblocking solution.Therefore, attempted to unblock tube sequentially with smaller syringes (60ml, 20ml, 10ml, 5ml) as per the upper gi surgery unblocking enteral feeding tube protocol.Felt release of tube unblocking, and the patient felt a short sharp pain below his right shoulder blade.Chest x-ray (cxr) requested, which reported ngt had split in two parts.Patient admitted for urgent oesophagogastro duodenoscopy (ogd) and computed tomography (ct).Patient had "perforation of his colonic interposition" and was treated with management of a perforation requiring total parenteral nutrition (tpn) and intravenous (iv) antibiotics.Patient was reported to discharged home with new ngt insitu.

Manufacturer Narrative

H6: 4247: investigation findings appropriate term/code not available: usage problem identified h6:4247: investigation findings appropriate term/code not available: blockage identified the device history record for lot 30234389 was reviewed and the product was produced according to product specifications.A picture of the alleged device was provided which confirmed that tubing was expanded to form a balloon shape which burst causing a separation of the tube, since the tube was clogged.The reported failure is more likely associated to the misuse of the product.Instructions for use calls for: tube maintenance 1.Follow your institution/facility/hospital protocol or clinician¿s order.2.It is recommended the tube be irrigated every 4 hours with up to 20 ml of water (up to 10 ml for infants or children) before and after medication administration or when feeding formula is interrupted.Warning: vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube.All information reasonably known as of 26 mar 2024 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 reported event but is relaying the information 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
• Type of Device: 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18327692
• MDR Text Key: 330848812
• Report Number: 9611594-2023-00185
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460802
• UDI-Public: 00350770460802
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-7361
• Device Catalogue Number: N/A
• Device Lot Number: 30234389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 63 KG