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

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.

• Brand Name: ARGYLE SALEM SUMP TUBE
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6379835
• MDR Text Key: 69127320
• Report Number: 6379835
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8888266122
• Other Device ID Number: KM6421307
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1