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

Model Number	8884715122E
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	01/12/2023
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 customer reported that the balloon ruptured and fell out.
Additional Manufacturer Narrative
The device history record (dhr) file could not be reviewed as the lot number was not provided by the customer.The physical samples nor photographs were not returned for evaluation therefore the reported complaint could not be confirmed nor related to a manufacturing process.The root cause cannot be determined without a physical sample to evaluate.Based on the available information, the reported issue was not confirmed to be manufacturing related.No action plan is deemed required at this time.The current process is running according to cardinal health patient recovery, medical segment the process for product specifications meeting quality acceptance criteria.This complaint will be used for tracking and trending purposes.Production personnel received an awareness notification to heighten awareness of the reported condition.

• 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: 16271979
• Report Number: 9612030-2023-03541
• Device Sequence Number: 12249566
• 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): 03/17/2023

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: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown