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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP DUAL LUMEN STOMACH TUBE,ANTI-REFLUX VALVE; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
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CARDINAL HEALTH 200, LLC SALEM SUMP DUAL LUMEN STOMACH TUBE,ANTI-REFLUX VALVE; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Model Number 8888266122
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
Event Type  malfunction  
Event Description
The anti-reflux valve used to plug the end of the ng tube was found to be broke in half.Gi contents were leaking from the end of the ng due to this equipment malfunction.A new anti-relux valve was ordered to replace the broken valve.The equipment was a 14fr ng salem pump dual lumen stomach tube by covidien.In this particular situation, the patient was on comfort cares/hospice and it was determined it would cause the patient too much distress to remove the device and replace it.Instead, we used a replacement anti-reflux valve to cap the tube when not in use to prevent further leaking.
 
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Brand Name
SALEM SUMP DUAL LUMEN STOMACH TUBE,ANTI-REFLUX VALVE
Type of Device
TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
785 fort mill hwy
fort mill SC 29707
MDR Report Key9897156
MDR Text Key185517817
Report Number9897156
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888266122
Device Catalogue Number8888266122
Device Lot Number1831018364
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2020
Event Location Hospital
Date Report to Manufacturer03/30/2020
Type of Device Usage N
Patient Sequence Number1
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