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

Model Number	461055E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
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 nasoenteric tube clogged following medication administration.There was no patient harm reported.
Additional Manufacturer Narrative
A device history record review could not be performed because the serial number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received at our decontamination lab.However, the used sample could not be forwarded to the manufacturing site for physical evaluation due to current customs policies.As a result, photos were instead taken of the sample by the decontamination lab and provided to the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue can be confirmed.The manufacturing process was reviewed and found that all tubes have been 100% tested and inspected.All tubes have passed the leak test before package and shipment.The leak test can cover the occluded issue, any tube block issue could be detected and hold in manufacturing line.At this time, the root cause of the reported issue could not be determined.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.A corrective action is not applicable at this time.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: 16236171
• Report Number: 1282497-2023-10728
• Device Sequence Number: 6522436
• Product Code: KNT
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/13/2023

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: 461055E
• Device Catalogue Number: 461055E
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/13/2023
• 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 Sex: Unknown