MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ENTERAL FEEDING TUBE; DH EF BALLOON TUBES PRODUCTS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/05/2021

Event Type  Death  

Event Description

It was reported the enteral feeding child expired due to aspiration.The feeding tube placed on (b)(6) 2021 due to a heart condition causing the patient to breathe "quickly" and experience difficulty drinking.Every time the patient tried to take a bottle she would choke, "which is why a feeding tube was needed." the gastrostomy tube (g-tube) was replaced on (b)(6) 2021.The patient was elevated or in a "swing" during feeds.The feedings were administered through a "joey pump" and believes it was a rate of 26ml/hr continuous feeds.On (b)(6) 2021 the caregiver noticed the g-tube was leaking from the stoma site.The caregiver called the on-call doctor and was told to put gauze under the feeding tube and wait since the patient had an appointment with her cardiologist in the morning where her gastro-intestinal (gi) physician could check.The feeding tube was secured down with tape.On (b)(6) 2021 the patient's machine went off to let the caregiver know there was no heartbeat and the patient was not responsive.The caregiver called 911 started cardio pulmonary resuscitation (cpr).During cpr formula was coming out of the patient's nose and mouth.The ambulance arrived and the patient was taken to the hospital.The patient passed away on (b)(6) 2021 child passed on at 10:10 am.(b)(6) old.Cause of death was noted as congestive heart failure.The cardiologist looked at x-rays taken post death where the right lung was collapsed and there was fluid in the lung.

Manufacturer Narrative

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.All information reasonably known as of 07-dec-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, inc.Complaint database and identified as complaint (b)(4).

Manufacturer Narrative

All information reasonably known as of 15-feb-2022 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.

Manufacturer Narrative

All information reasonably known as of 16-feb-2022 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.

Event Description

Feeding tube placed on (b)(6) 2021.

• Brand Name: UNKNOWN ENTERAL FEEDING TUBE
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12956892
• MDR Text Key: 281886794
• Report Number: 9611594-2021-00177
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 9 MO
• Patient Sex: Female