MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported the patient's feeding tube was found 10 cm out from the previously documented position, so the tube was reinserted and an x-ray was done to confirm the position.On the x-ray it was found that the feeding tube had fractured in the midportion of the tube.The tip of the proximal tube was in the esophagus, and the distal half of the tube was in the stomach.The distal portion was retrieved from the patient¿s stomach.

Manufacturer Narrative

The device history record (dhr) review could not be performed because no lot number was provided.One sample was received.Only the part of the tube up to the number 25 was received; the tip was not received.The sample presented a burst, the reported condition is confirmed, however the issue was not caused in the manufacturing plant.A walk through was performed of the manufacturing process.All process and controls were found properly followed.Production personnel perform a 100% visual inspection during the packaging process, to detect and discard any identified issues.The root cause could not be determined with the information available.No further actions are planned.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• 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: 18333938
• MDR Text Key: 330548126
• Report Number: 9612030-2023-03878
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other