MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461243E

Device Problem Obstruction of Flow (2423)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

The customer stated the iris tube was clogged at the distal end above the camera and they were not able to dislodge the clog using a clog zapper along with the guide wire.It also has a pin sized hole at the purple "y" connection.The tube was removed and replaced with another.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

H3 evaluation summary: the device history record (dhr) review could not be performed because a lot/serial number was not available.One sample was received for evaluation.No obvious structural abnormalities were found.Crystals formed during use can be clearly observed in the hole of the head.The manufacturing site did not detect any leaking on the returned sample.The pinhole at the purple y connection is only the injection point during manufacturing.The manufacturing site reviewed the manufacturing process of the tube assembly, testing, and inspections.Line touring was performed of the manufacturing process.All tubes 100% passed the leakage test.No occluded tube was found.The air leak test would discover an issue with a pin hole or occlusion.The site was not able to reproduce the leaking issue on the returned sample.The pinhole of the y-port is only the injection point.Some of the recommendation in the instructions for use (ifu) regarding clogging state the feeding tubes should be flushed frequently to prevent clogging; before and after feeding and administering medications.Only tap or sterile water should be used to flush.The kangaroo feeding tube with iris technology is for short term use.A corrective and preventative action (capa) will not be opened at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Type of Device: 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: 13731962
• MDR Text Key: 287006978
• Report Number: 1282497-2022-10681
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• 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
• Report Date: 04/19/2022

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: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1