MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORTRAK 2 NASOGASTRIC FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Patient with cortrak nasogastric feeding tube.Kub identified rhe tube was broken.On removal, the break was noted at 19cm.Gi consulted and recommended for natural passage of piece.Fda safety report id # (b)(4).

• Brand Name: CORTRAK 2 NASOGASTRIC FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 12487677
• MDR Text Key: 272465021
• Report Number: MW5104048
• Device Sequence Number: 1
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR