MAUDE Adverse Event Report: CARDINAL HEALTH / COVIDIEN SALEM TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 8888265124

Device Problems Flushing Problem (1252); Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

A 14 french salem tube used for placement.Unable to flush air to check placement once all ports capped.Unable to aspirate.Tube not in mouth, suspected proper placement.Tube removed and found to have no distal perforations, defective.Fda safety report id# (b)(4).

• Brand Name: SALEM TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH / COVIDIEN
• MDR Report Key: 11847749
• MDR Text Key: 251680072
• Report Number: MW5101395
• Device Sequence Number: 1
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8888265124
• Device Lot Number: 202200024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1