MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720221E

Device Problem Break (1069)

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 during the delivery of the nursing shift in the assessment, a gastrostomy tube is found outside the stoma, the broken tube balloon is evident, the doctor on duty is informed.No injuries were reported.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A physical sample was not received for the investigation, but three photos were provided.The affected component is purchased from an external supplier.As a result, the images were sent to the supplier with a complaint notification to initiate an investigation.Per the supplier, the pictures were reviewed, and the reported condition was confirmed; the balloon at the end of the device is discolored and deflated.Without a physical sample no further inspections could be performed, and a definitive root cause could not be determined.The supplier will continue to monitor any trends to determine the need for corrective actions.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 15507593
• MDR Text Key: 306253791
• Report Number: 9612030-2022-03403
• Device Sequence Number: 1
• Product Code: PIF
• 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: 11/18/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 11/18/2022
• 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