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

Model Number	461055E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states that the iris tube had a tube tear in the soft rubber v purple portion of the feeding tube between the two connectors.There was no harm reported.Additional information was received and stated that there was tube feeding leaking from the site.After talking to the nurse, the customer found out that the dale connector was very tight on the tube.They were wondering if when placing the connector, the nurse may have inadvertently torn the tube.The material of the tube is softer in that area.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.No sample has been received for the investigation.However, a picture was provided for the analysis.Upon review, it was found that there was a tear in soft rubber v purple portion of the feeding tube between the two connectors.A review through the manufacturing process was conducted.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 performed by the production personnel during the packaging process, to detect and discard any identified issue.Based on the customer feedback¿ they were wondering if when placing the connector, the nurse may have inadvertently torn the tube¿, it is possible that the y-port was torn due to improper external force during use.The torn y-port led to leakage problems during use.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa 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: 13541896
• Report Number: 1282497-2022-10679
• Device Sequence Number: 17192188
• 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,Followup
• Report Date (Section B): 03/16/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/17/2022
• 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 Sex: Unknown