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

Model Number 42-9368

Device Problems Break (1069); Complete Blockage (1094)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2020

Event Type  malfunction  

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 01 mar 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that an x-ray was performed on the patient to look for blockages in the nasogastric (ng) tube.The x-ray revealed that the tube had two blockages and was split into three parts.The patient was reported as having passed away.Per additional information received 2021-02-12, the patient died at the end of (b)(6).The death was not related to the reported event.There were no negative consequences to the patient as a result of the broken feeding tube.The pieces had been retrieved and no other medical intervention was required.

Manufacturer Narrative

A photo of the device involved in the reported event was sent to avanos for evaluation.Analysis of the picture determined that the tubing exhibited "ballooning" with complete rupture.While a root cause could not be conclusively determined, it is possible that it is user 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 (b)(6) 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 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.

Manufacturer Narrative

One used sample was provided for evaluation.Only the proximal portion of the tube was provided, the distal portion which had broken off was not returned.Examination and decontamination did not reveal any buildup of material inside the inner tube.The break was at the 35cm marking, and thin layers of material were seen.The complaint is still confirmed as reported, and the possible root cause remains as use related, as the instructions for use provided with the device instruct that vigorous force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 27 jul 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, 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 CONNECTOR
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11398729
• MDR Text Key: 240659152
• Report Number: 9611594-2021-00039
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460925
• UDI-Public: 00350770460925
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 42-9368
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 07/15/2021
• Supplement Dates FDA Received: 03/15/2021; 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 60