MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN ENTERAL ACCESS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNKNOWN ENTERAL ACCESS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that a patient had a wire guided nasogastric tube that had been connected appropriately to the kangaroo feeding.The feeding had to be stopped as they were planning a stomach tube placement later that day.The nurse could not disconnect the kangaroo set tubing from the port of the nasogastric tube.It was fully stuck and a piece of the port (ng tube) started to come off and then was fully off in order to get the tubing disconnected.The item code for the ng tube is unknown.Photos attached.

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event, and determined that through the provided photos, the port detached from the feeding tube.A device history record review could not be performed because a lot number was not received with the complaint.The investigation was carried out with the multifunctional team and all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.The root cause could not be confirmed as manufacturing related based on the available information.All information received will be used for further tracking and trending purposes.

• Brand Name: UNKNOWN ENTERAL ACCESS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16987665
• MDR Text Key: 315852848
• Report Number: 9612030-2023-03708
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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 Model Number: UNKNOWN ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1