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	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the kangaroo extension tube was added prior to the tube feed.Feeds run over 90 mins.Sixty minutes into the feed, the nurse noticed the feed leaked onto the mattress.The med port on the extension tube opened up too easily, even though it was closed prior to feed initiation.There was no patient harm.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.Because the sample was not provided for evaluation, the failure mode could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for 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; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17378032
• Report Number: 1282497-2023-10766
• Device Sequence Number: 12280115
• 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): 09/07/2023

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
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown