MAUDE Adverse Event Report: COVIDIEN/CARDINAL HEALTH 200, LLC SALEM SUMP WITH ENFIT CONNECTION; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 10884521582736

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Defective product, ports on multiple enfit connections for salem sump, dual lumen stomach tubes were unable to be turned.

• Brand Name: SALEM SUMP WITH ENFIT CONNECTION
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN/CARDINAL HEALTH 200, LLC
• MDR Report Key: 17418719
• MDR Text Key: 320150048
• Report Number: MW5120315
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10884521582736
• Device Catalogue Number: 280229
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose