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

Model Number	40-9366
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 08 jan 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.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 a corflo ng tube ¿broke in the patient." the customer stated, "it looks to me like the tubing expanded in one location." no patient injury reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The device history record for lot 0001000954 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The used tube was returned without any original packaging.There was no identified split/tear or separation of the tube; however, the tubing appeared to have expanded to form a balloon shape on the 14cm marking.A slight dirt or materials inside the tube was noticed when flushing.No clogging or blockages were experienced when flushing the tube.The root cause could not be conclusively determined.All information reasonably known as of 03 mar 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.

• 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: 9568498
• Report Number: 9611594-2020-00006
• Device Sequence Number: 18942226
• Product Code: KNT
• UDI-Device Identifier: 10680651460421
• UDI-Public: 10680651460421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 07/01/2024
• Device Model Number: 40-9366
• Device Catalogue Number: 104604201
• Device Lot Number: 0001000954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1