MAUDE Adverse Event Report: CARDINAL HEALTH COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE MULTI-FUNCTIONAL PORT WITH ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Lot Number 2311800364

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

Event Date 07/16/2023

Event Type  Injury  

Event Description

After nurse administered medication through a salem sump dual lumen stomach tube multi-functional port with enfit, nurse was unable to turn the lock stop due to the lock being stuck.

• Brand Name: COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE MULTI-FUNCTIONAL PORT WITH ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 17390030
• MDR Text Key: 319828507
• Report Number: MW5120002
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2311800364
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic