MAUDE Adverse Event Report: CARDINAL HEALTH PVC F TUBE 8FRX16IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 460604E

Device Problem Leak/Splash (1354)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that there was feed leaking at the connection to the tubing, under purple cap.They had to remove the tube and insert new one.There was no additional medical intervention required after the tube replacement.

Manufacturer Narrative

A decontaminated sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Upon a visual and functional inspection of the sample, the reported issue was confirmed; a leak was observed between the connector and the tube.A root cause analysis indicated placing a higher fr bushing in the solvent dispenser contributed to the reported issue.Actions have been taken to address the reported condition.A quality alert was also issued to alert manufacturing personnel as part of the quality containments actions.

• Brand Name: PVC F TUBE 8FRX16IN W ENFIT
• 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: 16710391
• MDR Text Key: 313026805
• Report Number: 9612030-2023-03671
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547209
• UDI-Public: 10884521547209
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 460604E
• Device Catalogue Number: 460604E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1