MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR 43IN W STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the feeding tube insertion proceeded on (b)(6) at 8:00 am and additional segregation at the end of the feeding tube was found during the regular x-ray examination on (b)(6) at 6:30 am.After notifying the medical department, the feeding tube was removed to confirm the actual separation.Per customer, it will be removed with an endoscope later.Additional information was received and stated that the weighted tip was detached.Per customer, the hospital has delivered the current situation to the patient and patient caregivers without proceeding further medical intervention/procedure to remove the end of the feeding tube.Through x-ray diagnosis, it was confirmed that one tungsten is in the stomach and three in the small intestine.The patient was fasting until (b)(6) 2023 and will eat from (b)(6) 2023, so the hospital will see if it can be removed with feces for now.The customer further stated that the patient has been moved from the intensive care unit to the general ward on (b)(6) 2023, and no serious problems have been reported due to the feeding tube.Further additional information is not available due to patient privacy protection from the hospital.

Manufacturer Narrative

Section h6 type of investigation should also include 4112 analysis of data provided by user/third party, as the customer has provided 5 pictures and upon picture analysis, the reported issue is confirmed.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 14-feb-2022.One sample was received for analysis.The sample was visually evaluated, and the reported issue is confirmed.A corrective and preventative action (capa) has been opened to further investigate this issue.

Event Description

The customer reported that the feeding tube insertion proceeded on (b)(6) at 8:00 am and additional segregation at the end of the feeding tube was found during the regular x-ray examination on (b)(6) at 6:30 am.After notifying the medical department, the feeding tube was removed to confirm the actual separation.Per customer, it will be removed with an endoscope later.Additional information was received and stated that the weighted tip was detached.Per customer, the hospital has delivered the current situation to the patient and patient caregivers without proceeding further medical intervention/procedure to remove the end of the feeding tube.Through x-ray diagnosis, it was confirmed that one tungsten is in the stomach and three in the small intestine.The patient was fasting until (b)(6) 2023 and will eat from (b)(6) 2023, so the hospital will see if it can be removed with feces for now.The customer further stated that the patient has been moved from the intensive care unit to the general ward on (b)(6) 2023, and no serious problems have been reported due to the feeding tube.Further additional information is not available due to patient privacy protection from the hospital.Additional information was provided by the customer and stated that the patient died since then.Therefore, there was no action conducted to remove the end of the enteral feeding.The hospital has confirmed that it had nothing to do with the patient¿s death and the defective product.

• Brand Name: ENTFLX 12FR 43IN W STYL 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: 16117705
• MDR Text Key: 308640117
• Report Number: 9612030-2023-03511
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup
• Report Date: 03/30/2023

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: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2204101164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/03/2023; 01/03/2023; 01/03/2023
• Supplement Dates FDA Received: 02/14/2023; 03/30/2023; 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1