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U.S. Department of Health and Human Services

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

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COVIDIEN MEDTRONIC COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE Back to Search Results
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.
 
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Brand NameCOVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE
Type of DeviceSALEM SUMP
Manufacturer (Section D)
COVIDIEN MEDTRONIC
minneapolis MN 55432 5604
MDR Report Key6533485
MDR Text Key74197619
Report NumberMW5069448
Device Sequence Number1
Product Code FEG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
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