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

Model Number	8884720858E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Foreign Body In Patient (2687)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the registered nurse (rn) was in room administering medications and was concerned for patient aspiration following immediately needing increased oral suction.The rn ordered chest x-ray for aspiration.The radiologist called the rn with report stating duo tube was broken in two pieces and distal pieces was sitting in esophagus and stomach.The rn called the provider and was ordered to remove proximal portion and call gastrointestinal (gi) for foreign body removal.The gi called back and decided to do an esophagogastroduodenoscopy in the morning.Additional information was received from the customer and stated that esophagogastroduodenoscopy was performed, and they were unable to remove the pieces.The patient was discharged in stable condition.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on 21-mar-2023.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a functional and visual evaluations to confirm the reported condition and determine the root cause.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• 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: 18682001
• Report Number: 9612030-2024-00036
• Device Sequence Number: 12301050
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2307202664
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/07/2024
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male