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

Model Number 8884721252E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported when the probe was inserted, the weighted tip came loose.The tip remained in the patient's sinus with no possibility of removal at the time.

Manufacturer Narrative

H4 device manufacture date was added.The device history record (dhr) review showed that manufacturing and inspection of the product was performed as per applicable procedures and validated process.Photos were provided showing the weighted tip was detached from the feeding tube.No sample was received for evaluation.The reported condition was confirmed through the photos.A walk through was performed of the manufacturing process and all process and controls were found properly followed.The exact root cause could not be determined with the available information.Based on the historical review, a corrective and preventative action (capa) was generated to further investigate the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Type of Device: 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: 18484211
• MDR Text Key: 332557782
• Report Number: 9612030-2024-00011
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (y/n): N
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2300301164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Date Device Manufactured: 03/01/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other