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	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Per customer, a 6-year-old female patient was hooked up to continuous feeds all night.The patient was being treated for fever.During morning bedside report, it was noticed that the feeding bag was leaking formula and letting air into the tubing.It seems like there was a little hole where the tubing meets the plastic cassette that attaches to the pump.The customer replaced it with another bag and there was no leaking with that bag.There was no harm reported.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• 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: 16490615
• Report Number: 1282497-2023-10741
• Device Sequence Number: 5849508
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 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: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female