MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 12FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715122E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
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 charge technologist for interventional radiology reported the enfit end is breaking below the actual connection on the kangaroo feeding tubes.Additional information received stated the device had a break at the feed and medication port causing a leak.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was unavailable.One feeding tube was received for evaluation.After performing a visual inspection, disassembly between the y-port body and enfit body connector was observed.The root cause is missing solvent in the assembly between the y-port body and enfit body connector.A walk through was carried out in the manufacturing area with the multifunctional team.A new dispenser of solvent was validated without change to the process.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR EN
• 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: 16485285
• Report Number: 9612030-2023-03605
• Device Sequence Number: 12452122
• Product Code: KNT
• UDI-Device Identifier: 10884521661622
• UDI-Public: 10884521661622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/03/2023

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: 8884715122E
• Device Catalogue Number: 8884715122E
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown