MAUDE Adverse Event Report: CARDINAL HEALTH KANG Y-SITE EXT SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884705008
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient was found in bed laying in leaked tube feed.The feed was noted to be in a puddle on the floor and covering the bed and patient.On inspection of the line, the main port was open and the tube feed line was connected to y site port.As for the device, they believe there is a problem when the feed line is put into the secondary port to run.They find that it causes the main port to pop open from pressure.When the feed line is in the main port, the y site or secondary port does not open.If the feed line will no longer stay in the main port then they should be changing the extension tube.The impact of the incident was that the patient missed a feed and required a thorough bed bath.The patient is at risk for skin break down but no injuries were reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: KANG Y-SITE EXT SET
• 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: 16912354
• Report Number: 9612030-2023-03696
• Device Sequence Number: 6356533
• Product Code: KNT
• UDI-Device Identifier: 10884521000063
• UDI-Public: 10884521000063
• 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): 07/25/2023

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: 8884705008
• Device Catalogue Number: 8884705008
• Device Lot Number: 2225617964
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/25/2023
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown