MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the end of this feeding tube snapped and was inside a patient; however, it was able to be retrieved.

Manufacturer Narrative

See section b3 for date of event.See section d5 for the operator of device.See section e4 ¿ checked initial reporter also sent report to fda as ¿yes¿.See section g2 report source - checked report source health professional, user.Facility and other - entered text to include medwatch report #mw5113081.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.As an awareness notification, a quality alert has been shared with production personnel.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• 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: 15816082
• MDR Text Key: 307568741
• Report Number: 9612030-2022-03469
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1