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

Model Number 20-9438

Device Problem Malposition of Device (2616)

Patient Problems Hypoxia (1918); Cough (4457)

Event Date 09/02/2021

Event Type  Injury  

Event Description

It was reported via fda medwatch / fda user facility report # (b)(4) the following information: rn (registered nurse) attempted to place corpak and patient began coughing and sp02 dropped to 82% a bedside kub (kidney, ureter, and bladder x-ray) was performed that showed the corpak in the right lung with an obvious right sided pneumothorax.Additional information received 15-oct-2021 states medical intervention was required and a chest tube was placed at 1240 on (b)(6) 2021.The patient was discharged on comfort care at 2130 on (b)(6) 2021.

Manufacturer Narrative

There is no information provided regarding the return of the actual complaint product to the manufacturer.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 08-nov-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.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).

• 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
• 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: 12781333
• MDR Text Key: 282120293
• Report Number: 9611594-2021-00157
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770458069
• UDI-Public: 00350770458069
• 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,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20-9438
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White