MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 18 FR, 2.5 CM - 45 - NON-ENFIT; DH EF BALLOON TUBES PRODUCTS

Model Number 0270-18-2.5-45

Device Problem Migration (4003)

Patient Problems Pneumonia (2011); Sepsis (2067)

Event Type  Injury  

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.Root cause could not be determined.All information reasonably known as of 13-feb-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

It was reported the enteral feeding tube dislodged and began to coil up in the patient's esophagus.The patient was hospitalized with sepsis and pneumonia.Additional information received 20-jan-2020 stated the patient received antibiotics during hospitalization.The patient was hospitalized for two weeks for the sepsis and pneumonia.No additional information was provided.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 18 FR, 2.5 CM - 45 - NON-ENFIT
• 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9707421
• MDR Text Key: 187067017
• Report Number: 9611594-2020-00017
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770956640
• UDI-Public: 00350770956640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2020

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: Lay User/Patient
• Device Model Number: 0270-18-2.5-45
• Device Catalogue Number: 109566402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 44