MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720205E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The customer reported that a patient with a gastrostomy tube with a female to male enfit connector, which shows a broken enfit adapter and it is possible to unscrew the nutrition equipment from the gastrostomy tube.Additional information received on (b)(6) 2022 clarified that it is not possible to unscrew the nutrition equipment.The device did not separate/detach on it's own.Leaking did occur since the connector broke.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record file was reviewed, and no discrepancy was found according to the failure reported.A physical sample was not returned for evaluation.However, a picture was provided and reviewed.After performing a visual inspection, a damaged connector (y-port) was observed; broken from y-union.The reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR 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: 14435542
• MDR Text Key: 292031838
• Report Number: 9612030-2022-03255
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: 2118109264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2022
• Type of Device Usage: A
• Patient Sequence Number: 1