MAUDE Adverse Event Report: CARDINAL HEALTH 10FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461043E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the one of the two luer lock port broke, causes leaking and issues with ng tube.Per customer, the other valve was not broken but unable to give feedings with other broken port due to loss in pressure.When attaching the tube feeding to port, it cannot be tightened to tight if not, it can cause this issue of the port breaking.Additional information was received and stated that the port was cracked but not detached.There was no patient harm reported.
Additional Manufacturer Narrative
Section d3 (manufacturer name, city and state): originally reported as covidien, calle 9 sur no.125 cuidad ind, tijuana, mexico, 22500 and should be cardinal health, 777 west street, mansfield, massachusetts, united states, 02048 section g1 (manufacturing site name and address): originally reported as covidien, calle 9 sur no.125 cuidad ind, tijuana, mexico, 22500 and should be cardinal health, 777 west street, mansfield, massachusetts, united states, 02048 section g8 (manufacturer report number): the registration number was originally reported as 9612030 and should be 1282497.

• Brand Name: 10FR 43 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: 12196419
• Report Number: 9612030-2021-02992
• Device Sequence Number: 4848176
• Product Code: KNT
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 11/10/2021
• 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