MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720205E

Device Problem Material Rupture (1546)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Evidence of a displaced gastrostomy tube was verified.The gastrostomy tube balloon was broken.

Manufacturer Narrative

The device history record (dhr) file for the reported lot number was reviewed, and no discrepancies were found relating to the reported issue.The manufacturing process was reviewed.The physical samples were not returned; however, a digital image was received for evaluation.The digital image was visual inspected; a balloon broken can be observed from photo sample received.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.

Manufacturer Narrative

Updated section h6.Health effect - impact code.Updated section b5.Describe event or problem.

Event Description

Per additional information received, the balloon was punctured and the process of inserting the probe had to be performed again.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR 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: 16137348
• MDR Text Key: 308241259
• Report Number: 9612030-2023-03519
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205E
• Device Catalogue Number: 8884720205E
• Device Lot Number: 2132736264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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
• Patient Sex: Male
• Patient Weight: 65 KG