MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461255E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
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 reported that the patient was transferred from another unit right at shift change.The patient had a dobhoff feeding tube with iris that was broken at the connecting y site.The nurse was unable to administer medication or tube feed without it leaking out of the other site.The patient tube feeds were postponed until a new one was placed.The broken feeding tube was discarded.The tube had been in place for 16 days.
Additional Manufacturer Narrative
The device history record (dhr) is established based on a serial number located on the device.Since no serial number was provided by the customer, the dhr could not be reviewed.A sample was not returned for evaluation.If a sample is received at a later date, the complaint will be reopened and updated accordingly.The manufacturing process of the y-port assembly, test and inspection was reviewed by the supplier, no issues found.The supplier performs a leak test during production.The supplier also reviewed y-port failure history at the production line and no y-port crack/detached issues were found in 2022.Furthermore there are four inspection stations which can detect a y-port crack issue during manufacturing.Further analysis is not able to be performed at this time due to the limited information.Based on the available information, a root cause cannot be determined.No corrective actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 12FR 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: 15027082
• Report Number: 1282497-2022-10705
• Device Sequence Number: 4583095
• Product Code: PIF
• UDI-Device Identifier: 10884521742239
• UDI-Public: 10884521742239
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 461255E
• Device Catalogue Number: 461255E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Ethnicity: Hispanic