MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 43INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports: a request was made to take the feeding tube out of the patient.It was verified that the edge was broken.An endoscopy was necessary to remove the fragment inside the patient's stomach.The client doesn't have the sample anymore.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Additional Manufacturer Narrative
The device history record for each lot affected was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.Five photos were submitted for evaluation.Based on the observation of the photos, it confirms that a balloon formed in the tube which caused it to break.A gemba walk was performed at the manufacturing site where the process was reviewed.All process and controls were properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed on the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified defects.At this time the device has not been returned thus, an exact root cause could not be determined, minimizing the ability to further investigate and confirm that the issue was related to the device.The product design safety, performance, and effectiveness remain the same or better.No new hazards, hazardous situations, harms, or failure modes are introduced due to this event, and the risk profile remains unchanged that would drive updates to the current risk management files.Based on the above assessment, no further actions are being pursued as a result of the complaint.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19514981
• Report Number: 1423537-2024-00024
• Device Sequence Number: 17973539
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2232602764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG