MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 36INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the feeding tube was cracked one inch along the length of the tube at the y-site connection.When feed was initiated through the tube, it was leaking at the crack.The tube had to be removed and replaced with a new tube.This was very invasive for the young patient.Per additional information received on 11aug2022, there was no patient injury.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on september 08, 2021.Two photos and one physical sample were received for investigation.The sample was evaluated, and the reported condition was confirmed.A corrective and preventative action has been initiated to address the reported condition.

• Brand Name: ENTRFLX 8FR 36INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 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: 15296432
• Report Number: 9612030-2022-03366
• Device Sequence Number: 12338425
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/11/2022

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Device Lot Number: 2124302664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown