MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461255E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
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 iris purple hub at the end became separated completely from the y port.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that the y-port was damaged.The device history record (dhr) for this product is established based on the serial number of the device however no serial number was provided therefore the dhr could not be reviewed.The suppliers reviewed their manufacturing processes, testings, inspections, and established controls; no issues were found.The tests and inspections can 100% detect y-port damage during the assembly process.Based on the available information it was determined that the y-port had been damaged during use by external force as there is no risks to cause the y-port damage during the manufacturing process.No actions are required at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: 12FR 55 IRIS FEEDING TUBE ENF
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17013107
• Report Number: 1282497-2023-10760
• Device Sequence Number: 18031101
• Product Code: PIF
• UDI-Device Identifier: 10884521742239
• UDI-Public: 10884521742239
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/15/2023

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: 461255E
• Device Catalogue Number: 461255E
• 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: 05/26/2023
• Supplement Report FDA Received Date: 06/15/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown