MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported : medical device enteral feeding tube 10 fr with uni tungsten tip used in patient identified in the report, which is covered, requiring change.Per additional information received on 27feb2023, there was an obstruction.The medical device was replaced.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) file could not be reviewed as it was not provided by the customer.The physical samples were not returned for evaluation therefore the reported complaint could not be confirmed nor related to a manufacturing process.The root cause cannot be determined without a physical sample to evaluate.A walk through of the manufacturing process was conducted and determined that the current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.Based on the analysis, the observed occurrence of harm (0) is 0.00280% (1, improbable) which is below the range of the expected occurrence of harm (0) (2, remote).Therefore, no action plan required at this point.The manufacturing facility will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield GA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16468061
• Report Number: 9612030-2023-03591
• Device Sequence Number: 5064007
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 8884721088
• Device Catalogue Number: 8884721088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/06/2023
• 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: Female