MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8200-16

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, an avanos mic jejunal feeding tube was placed using divinci laparoscopic device.On (b)(6) 2023, a ct (computed tomography) scan was ordered for follow up on another unrelated procedure.An object was identified to be in his pelvis and the surgeon opted to take the patient to the or (operating room) for a possible retained foreign object.A diagnostic laparoscopy was performed and a clear piece of tubing was removed.The tubing was noted to be a portion of the avanos mic jejunal feeding tube that was placed on (b)(6) 2023 that apparently broke off during the procedure.The remaining portion of the j-tube was in place.

• Brand Name: AVANOS MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18425582
• MDR Text Key: 331835585
• Report Number: MW5149698
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8200-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention