MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR;43IN W/STYL YPOR; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884721252E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported a y port connection failure of the nasogastric tube.No patient or staff injury.The feeding tube was replaced in patient.Additional information received on 14-feb-2022 stated that the y-port had a section detach.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A photo and the physical device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: ENTRFLX 12FR;43IN W/STYL YPOR
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13573218
• MDR Text Key: 285993694
• Report Number: 9612030-2022-03171
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2019613964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Type of Device Usage: A
• Patient Sequence Number: 1