MAUDE Adverse Event Report: CARDINAL HEALTH 10FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461055E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
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 stated the insertion was uncomplicated.Days later the primary rn noticed the tube was leaking from the hub.On assessment the hub was split in the middle between the ports.The tube was flushed with water and was leaking from the split.The feeding tube was removed and another was placed at bedside without difficulty.
Additional Manufacturer Narrative
The device history record (dhr) is established based on the serial number stick on the device.No serial number (sn) was available, the dhr could not be reviewed.The lot number was not available so the manufacturing date and y port lot could not be tracked.The sample was not available because it was discarded.From the photo provided, it was found that there was a tear in the soft rubber y purple portion of the feeding tube between the two connectors.The manufacturing process of the y-port assembly tests and inspection was reviewed.The leak test was performed following specifications.The leak test can detect a y-port leak issue.The final inspection station has an inspector to check the y-port for cracks.The final inspection station can detect the kind of y-port issue reported as well.All process and controls were found properly followed, including sub-assemblies, finished product assembly, and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.In addition, quality control (qc) inspections were found performed to the product for material release and a 100% visual inspection was performed by the production personnel during the packaging process in order to detect and discard any identified issues.A leak test is conducted as a qc inspection per procedure.From the investigation, the supplier confirmed the production team followed the specification and instructions.The supplier was unable to determine the root cause or the reported issue.No action will be taken at this time.Should a sample become available in the future the complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 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: 13392635
• Report Number: 1282497-2022-10677
• Device Sequence Number: 4382795
• Product Code: PIF
• 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,Followup
• Report Date (Section B): 03/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/14/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown