MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 43INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the new small bore feeding tube from enfit is leaking at the y-site.There is a hair line crack in the plastic between the lip of the port and the purple part of the tubing, causing tube feeds and enteral medications to leak and collect around they site.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Additional information.The device history record (dhr) was reviewed showing no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Sample evaluation could not be performed because no sample nor photo was available.The investigation was carried out with the multifunctional team, all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.The root cause could not be determined as the complaint was not confirmed.A risk assessment was performed to determine the occurrence of the reported failure mode.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR 43INW 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: 16111988
• Report Number: 9612030-2023-03509
• Device Sequence Number: 20542879
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• 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: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2220603164
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/06/2023
• Date Device Manufactured: 08/10/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown