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

Model Number 42-9368

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem Cough (4457)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 02 sep 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 inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported the device had been in use for 10 days when "nursing staff reported patient coughing when ngt [nasogastric tube] flushed with water.Ngt position had been confirmed on cxr [chest x-ray].Looking at the notes, the ngt was blocked on (b)(6) 2021 and nursing staff had unblocked using 20ml, 10ml, and 5ml syringes.The ngt had not been used for feeding since it was unblocked as [the patient] coughed when it was flushed.When we assessed we could hear air hissing when pushing air through the ngt.Nasal bridle also in situ.Unclipped from bridle and tube pulled back.Split tube observed at approximately 45cm.Ngt removed and new ngt inserted." additional information has been requested but not yet received.

Manufacturer Narrative

A sample was received for evaluation and the investigation remains in progress at this time.All information reasonably known as of 24 sep 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 returned for evaluation.The tubing appeared damaged and discolored.As part of the decontamination process, the tube was flushed and a resistance was felt, and some brownish substances were were flushed out of the tube.There was a split/tear in the tube between the 42cm and 41cm marking.The split did not appear to have a jagged edge.The complaint is confirmed with no root cause determined.All information reasonably known as of 05 oct 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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECT
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12421523
• MDR Text Key: 280946585
• Report Number: 9611594-2021-00117
• 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: 10/06/2021

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: 09/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 09/30/2021
• Supplement Dates FDA Received: 09/24/2021; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 58