MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN, DH CORTAK DISPOSABLES

Model Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

The avanos medical inc.Investigation confirmed the device was a cortrak nasogastric (ng) tube; the registration site for the device is 9611594.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.The root cause could not be determined.All information reasonably known as of (b)(4).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 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.Device not returned.

Event Description

Avanos medical inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 9611594-2023-00064 for the first report.Refer to 9611594-2023-00066 for the third report.Refer to 9611594-2023-00067 for the fourth report.Refer to 9611594-2023-00068 for the fifth report.Medwatch/ fda user facility mw report (b)(4) reported a safety event involving cortrak tube placement resulting in iatrogenic pneumothorax, the patient¿s current condition was not reported.

• Brand Name: UNKNOWN, DH CORTAK DISPOSABLES
• Type of Device: DH CORTAK DISPOSABLES
• 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: 16923712
• MDR Text Key: 315171328
• Report Number: 9611594-2023-00065
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2023

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 Model Number: UNKNOWN
• 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: 04/21/2023
• Initial Date FDA Received: 05/12/2023
• 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): Other