MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720221E

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a respiratory therapy patient had enteral feeding leakage due to tracheostomy.The doctor on duty was informed, who referred to the cessation of the patient's nutrition.Additionally, nutritional support was discussed and a rupture in the balloon was observed because a new gastrostomy tube must be passed.Per additional information received, it is unknown whether the balloon rupture was clean or fragmented.There was no medical intervention required and no patient injury reported.The device was replaced with another device with the same characteristics.

Manufacturer Narrative

A sample will not be returned for evaluation.The device history record file was reviewed, and no discrepancies were found relating to the reported issue.A sample analysis could not be performed since no photos or physical samples were returned for evaluation.Based on the available information the reported issue was not confirmed therefore a root cause cannot be determined.No corrective and preventive action is required at this time.The current process is running according to product specifications and meeting quality acceptance criteria.The complaint will be reopened if a sample is received at a later date.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR 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: 15539808
• MDR Text Key: 305841814
• Report Number: 9612030-2022-03411
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

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: 8884720221E
• Device Catalogue Number: 8884720221E
• Device Lot Number: 212085646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 10/25/2022
• Date Device Manufactured: 07/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1