MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
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 enfit luer lock end fell out.Presently held with luer lock from baxter iv tubing.Feeding tube will be changed out.
Additional Manufacturer Narrative
One photo was provided for evaluation.Through the photo the disassembly of the enfit body connector from the y port body was visible.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A gemba walk was carried out in the manufacturing area with the multifunctional team however based on the available information and without a physical sample to visually and functionally examine, an exact root cause was unable to be determined.No actions are required at this time.If the physical sample is returned at a later date, the investigation will be reopened and updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; 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 st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16645055
• Report Number: 9612030-2023-03658
• Device Sequence Number: 20363546
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2134806464
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/22/2023
• Date Device Manufactured: 12/20/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown