MAUDE Adverse Event Report: CARDINAL HEALTH 10FR 55 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461055E
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	06/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one of the feeding ports on the patient¿s duotube broke off during feeding, so the tube had to be removed and replaced.The tube was placed on (b)(6) 2021 and the break occurred on (b)(6) 2021.There was no patient harm reported.Additional information was received from the customer and stated that the purple port was detached, and it was unknown if there was any leak occurred.
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
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.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 55 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 12848659
• Report Number: 1282497-2021-10656
• Device Sequence Number: 4265891
• Product Code: KNT
• UDI-Device Identifier: 10884521742208
• UDI-Public: 10884521742208
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/07/2022
• 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: 82 YR
• Patient Sex: Female