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

Model Number	460604E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2023-03671
• Device Sequence Number: 7397222
• Product Code: PIF
• UDI-Device Identifier: 10884521547209
• UDI-Public: 10884521547209
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 460604E
• Device Catalogue Number: 460604E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown