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

Model Number 77100FD

Device Problems Detachment of Device or Device Component (2907); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 313358829
• Report Number: 9612030-2023-03664
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• 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
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female