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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE SALEM SUMP TUBE TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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COVIDIEN ARGYLE SALEM SUMP TUBE TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Catalog Number 8888266122
Device Problems Break (1069); Detachment Of Device Component (1104); Suction Problem (2170); Tear, Rip or Hole in Device Packaging (2385); Noise, Audible (3273)
Patient Problems Nausea (1970); Pain (1994); Abdominal Distention (2601)
Event Date 01/29/2017
Event Type  malfunction  
Event Description
A couple issues were reported about nasogastric tubes (ngt): ngt placed and the tube developed what appeared to be a hole in it, was making a gurgling sound. When i flushed it the patient reported being able to feel the fluid in her throat. Doctor was notified. He's going to examine it in the am and determine what needs to happen. This particular equipment failure is a patient safety issue led to increased pain, nausea, distended abdomen, etc. Patient was connected to ngt for a couple of days and had him at continuous suction, noticed it was not working properly, tried to see if it was clogged and tried some methods to get it working. We found a large hole in the ngt where the anti-reflux valve meets with the other part of the tube. Very large hole and unable to get it to seal. This may require the tube being replaced again if the patient is unable to get along without it. Anti-reflux valve cap broke off in the tube.
 
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Brand NameARGYLE SALEM SUMP TUBE
Type of DeviceTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key6379835
MDR Text Key69127320
Report Number6379835
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8888266122
Other Device ID NumberKM6421307
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2017
Event Location Hospital
Date Report to Manufacturer02/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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