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

Model Number 40-7361

Device Problem Break (1069)

Patient Problems Hypoxia (1918); Respiratory Distress (2045); Foreign Body In Patient (2687)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2019 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 patient had a nasogastric tube (ngt)/feeding tube in place for 5-weeks.The patient underwent a gastroscopy on (b)(6) 2019, the ngt remained in place during the scope.When the patient returned from the gastroscope procedure it was noted the ngt was found to be inserted further into the patient¿s gastrointestinal (gi) tract.The patient had a chest x-ray prior to use, the x-ray was reviewed and ngt was cleared for use.When attempting to flush the ngt resistance was met.As per protocol the ngt was flushed with warm water and smaller enteral syringes were used.While flushing the ngt, sediment from old feed solution was noted to be pulled back into the syringe.While using a 6ml syringe, resistance lessened and the nurse was able to flush the ngt.The patient became distressed and unable to breathe.Staff assistance was called, the patient was repositioned and oxygen levels were less than 95%.The patient appeared to be settling, the ngt was then flushed with 50ml of water, while another nursing staff member and doctor were in attendance.The patient was settled during the ngt flush and the doctor ordered for the ngt feeds to be resumed.The patient had two met (medical emergency team) events called overnight.During the 0700 met call, the ngt was removed and only the top section of the tube was removed, the tube had broken in half.An x-ray was performed, at 0900 the doctor reviewed the chest x-ray results.The chest x-ray results noted the remaining segment of the ngt was high in the patient's throat.The ear, nose and throat (ent) team was notified by the home medical unit, the ent doctor came and was able to remove remaining portion of ngt.The patient was reported to be in stable condition after the broken ngt segment was removed.

Manufacturer Narrative

The actual device was received.The device was assessed and failure was not confirmed.The root cause was not established.All information reasonably known as of 16-nov-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 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

One used sample was received.No product packaging was received.The product did not contain a lot number identification.The device was evaluated and the failure was confirmed.A root cause was not identified.All information reasonably known as of 02-dec-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 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

Additional information received 02-nov-2022, coroner's report: identity of the deceased 2.On (b)(6) 2019, (b)(6), born (b)(6) 1951, was visually identified by her daughter, (b)(6).3.Identity is not in dispute and requires no further investigation.Medical cause of death 4.Forensic pathologist dr v.F., from the victorian institute of forensic medicine (vifm), conducted an examination on (b)(6) 2019 and provided a written report of her findings on (b)(6) 2019.5.The post-mortem examination revealed that m.T.L.E.Had some scattered bruising and a drain containing dark brown bilious fluid in the epigastrium and the right lateral abdomen.A post-mortem ct scan showed patchy increased lung markings with radiopaque material within the liver.6.Dr v.F provided an initial opinion that the medical cause of death was l(a) aspiration pneumonia complicating gastroscopy to remove a broken nasogastric tube; l(b) complications of liver transplantation due to autoimmune hepatitis.7.I note that the information available to dr v.F during her examination was a police form 83 summary of circumstances, a post-mortem ct scan, and an e-medical deposition form clinical summary from the austin hospital which stated, "severe aspiration episode based on liver transplant unit on the (b)(6) 2019 following a gastroscope to retrieve a broken not fi"om oesophagus".This incorrect summary of the ngt rupture incident appears to have been copied from the medical admission entry at the time of m.T.L.E.'s transfer to the palliative care unit.8.Coroner o sought a supplementary report from vifm, which was completed by professor d.R., deputy director - head of forensic services, on (b)(6) 2021.Professor d.R.'s report confirmed that the information provided to dr v.F.For the purposes of her examination was incorrect, leading to an inaccuracy in the initial cause of death.Upon review of m.T.L.E.Complete medical record, professor d.R.Proposed that the cause of death be modified to: l(a) aspiration pneumonia secondary to a ruptured nasogastric tube in the setting of tube management and associated with a recent gastroscopy l(b) complications of liver transplantation due to autoimmune hepatitis.9.I accept professor d.R¿s opinion.

Manufacturer Narrative

All information reasonably known as of 23-nov-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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO
• Type of Device: DH CPK NG TUBES
• 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: 9182638
• MDR Text Key: 173722174
• Report Number: 9611594-2019-00190
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-7361
• Device Catalogue Number: 104602900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Death
• Patient Age: 68 YR
• Patient Sex: Female