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

Model Number	461055E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nasal jejunal tube was placed without difficulty.The wire was left in place for rn to remove post x-ray.X-ray was obtained in proper position without evidence of kink.At approximately 1840 #1 informed that the line was kinked.Also, #1 noted a small crack in the tube where fluid was dripping out on the proximal end of the tube.A new tube is being placed.On removal, clog was still noted.No injuries were 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.There were no samples or photos received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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: 15743009
• Report Number: 1282497-2022-10720
• Device Sequence Number: 5850986
• Product Code: KNT
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• 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
• Report Date (Section B): 11/07/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown