MAUDE Adverse Event Report: CARDINAL HEALTH CONNECT FEED STE 1000ML NS; PUMP, INFUSION, ENTERAL

Model Number	77100FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rn entered the patient's room and found the feeding tube leaking and with air in the tubing (feed was complete).There was approximately 20ml of formula on the ground.Rn looked closer at the set and noticed the connection between the tubing from the bag and the connection to the pump was not sealed and disconnected completely as she was inspecting it.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.Because the sample was not available for evaluation, the failure mode could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: CONNECT FEED STE 1000ML NS
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17001758
• Report Number: 1282497-2023-10759
• Device Sequence Number: 6579941
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 77100FD
• Device Catalogue Number: 77100FD
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Female