MAUDE Adverse Event Report: COVIDIEN MEDTRONIC COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2017

Event Type  malfunction  

Event Description

The white portion of the anti-reflux valve broke off and became lodged in the outer opening of the main tube of the covidien sales sump, dual lumen stomach tube.This was the second time that this had happened with this type of tube with this pt in a 24 hr period.Per the reporter, the anti-reflux valve seems to be made from a different type of material.

• Brand Name: COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE
• Type of Device: SALEM SUMP
• Manufacturer (Section D): COVIDIEN MEDTRONIC; minneapolis MN 55432 5604
• MDR Report Key: 6533485
• MDR Text Key: 74197619
• Report Number: MW5069448
• Device Sequence Number: 1
• Product Code: FEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 88