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

Model Number 8884715122E

Device Problem Material Rupture (1546)

Patient Problem Unintended Extubation (4564)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the balloon ruptured and fell out.

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
• Type of Device: 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
• MDR Text Key: 308474646
• Report Number: 9612030-2023-03541
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521661622
• UDI-Public: 10884521661622
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1