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

Model Number	8884721252
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9612030-2023-03511
• Device Sequence Number: 12176037
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023; 01/03/2023; 01/03/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/14/2023; 03/30/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown