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

Model Number	77100FD
Medical Device Problem Codes	Detachment of Device or Device Component (2907); 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
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: i 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.I 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 i was inspecting it.This is at least the third instance of a kangaroo connect feeding set leaking like this that i have heard about.I notified the charge nurse, bagged the item, and left it on the desk.
Additional Manufacturer Narrative
A device history record review could not be reviewed since a valid lot number was not provided.One used sample was received at the manufacturing facility for evaluation.A visual and functional inspection was performed and found that one line detached from the cassette.The set was received broken.The upstream tube (the tubing before the purple cassette) and downstream tube (the tubing after the purple cassette) were not connected properly to the set.Both tubes seemed to be properly sized so that they would fit in the set under normal circumstances, but both tubes were disconnected from the set.This was checked by successfully placing both tubes in the proper places in the purple cassette to check if they fit.The disconnected upstream and downstream tubing both lacked the distinct ¿cloudy¿ look that tubes have when a solvent adhesive is present.This indicates that there was not enough solvent adhesive placed on the tube during the manufacturing process to withstand normal use.The root cause and corrective action investigation will be documented through a formal corrective/preventative action (capa).
Additional Manufacturer Narrative
Corrected data: section d4: lot number - the original lot number does not correspond to the reported product therefore the lot number has been updated to "unknown." this field should remain blank.Section g: contact office - manufacturing site - the reported lot number was reported incorrectly therefore the manufacturing site has been updated.

• 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: 16746701
• Report Number: 9612030-2023-03664
• Device Sequence Number: 18281743
• 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,Followup
• Report Date (Section B): 08/23/2023

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
• Device Lot Number: 2227034764
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 03/29/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/12/2023; 08/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female