MAUDE Adverse Event Report: CARDINAL HEALTH ENTRIFLEX 8FR 36IN W O STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720817E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
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 the feeding tube is not functioning properly, it is leaking when in use.Additional information received stated the device is leaking where the clear tubing and the purple connector attached.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because no lot number was available.The current process and controls were found to be followed as per procedure.A sample analysis could not be performed because no photo or sample was available for evaluation.The exact root cause could not be determined.A corrective and preventive action has been initiated to address the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRIFLEX 8FR 36IN W O STYLET
• Common Device Name: 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: 16495029
• Report Number: 9612030-2023-03626
• Device Sequence Number: 6366797
• Product Code: KNT
• UDI-Device Identifier: 10884521582934
• UDI-Public: 10884521582934
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 8884720817E
• Device Catalogue Number: 8884720817E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/26/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown