MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN NASOGASTRIC TUBE; DH CPK NG TUBES

Model Number UNKNOWN

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Vomiting (2144)

Event Date 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

Fda medwatch/fda user facility report #(b)(4) is included as an attachment.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 03 apr 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 Description

Fda medwatch / fda user facility report # (b)(4) received on 13-mar-2020, and the following information was provided: "patient admitted with existing 6fr ng [nasogastric] tube in place.Rn [registered nurse] describes the kangaroo pump 'continuously alarming back flow.' rn disconnected the feeds from the patient and flushed tubing with 5 ml syringe using pulsatile flush.It was initially sluggish followed by free flow.Feeds restarted.Approximately 5 minutes later the secretions from ett [endotracheal tube] changed consistency and looked like potential feeds.Approximately two weeks later, feeds were paused, md [medical doctor] notified.Doctor assessed and decided it was not feeds.Feeds restarted.X-ray called per rn request the next day, tip in correct position.Next day, emesis of undigested feeds pooling in mouth.Feeds stopped for remainder of the night.In reviewing x-ray in morning the tube uas found to be completely split in two pieces within patient." original intended procedure was "continuous feeds.Patient here for respiratory failure." date of event shown only as "(b)(6) 2019." "patient is a (b)(6) month old with a 6fr feeding tube.Family requested to continue having 6fr feeding tube at (b)(6) 2019 clinic visit.Tube was advanced from ng to nj [nasojejunal] tube on (b)(6) 2019.Nurse describes the consistency of the fortified formula as a reason the pump began alarming.Formula was similac pro-advance 24kcal.".

Manufacturer Narrative

Additional information provided for b3: date of event.All information reasonably known as of 22 apr 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: UNKNOWN NASOGASTRIC TUBE
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9927114
• MDR Text Key: 199254827
• Report Number: 9611594-2020-00055
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2020
• Patient Sequence Number: 1
• Patient Age: 13 MO