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

Model Number 20-4432

Device Problems Break (1069); Obstruction of Flow (2423)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 28 may 2019 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported that a "ng [nasogastric] tube broke and a portion was retained inside the patient." the report stated "one patient of (b)(6) years and with pneumoconiosis, return to the hospital after 10 days because the enteral feeding tube was occluded and when it was removed it did not have the tip of tungsten.X-rays showed that the tip was in the intestine." additional information received on 14-may-2019 stated the patient in this incident did expire a few days after the event but the cause of death was not attributed to the device; patient expired from his previous critical condition.No patient harm was noted due to the retained ng tube or x-ray.The patient expired prior to expelling the retained portion of the tube.Additional details of the event were provided as "chief of nursing receives the patient with the obstructed probe so he removes and places a new one, detects the withdrawal without the tip of tungsten; the previous shift nurse tried to wash it to remove the occlusion but could not.They confirm case when they do x-rays to see the second probe.There was no detail of the cause of the occlusion of the first probe.".

Manufacturer Narrative

The device history record for the reported lot number, 0002955544, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 30-oct-2019 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 halyard health 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
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8649349
• MDR Text Key: 146345397
• Report Number: 9611594-2019-00110
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 20-4432
• Device Catalogue Number: 104573700
• Device Lot Number: 0002955544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR