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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORFLO; TUBE, GASTROINTESTINAL
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AVANOS MEDICAL, INC. CORFLO; TUBE, GASTROINTESTINAL Back to Search Results
Model Number 40-9438
Device Problems Complete Blockage (1094); Material Perforation (2205)
Patient Problem Low Oxygen Saturation (2477)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
Patient's nasogastric tube became clogged with baclofen dose.Through troubleshooting, repositioning, and the use of (b)(6), the tube began to flush easily.Enteral lorazepam was administered without issue three hours later.At midnight a chest x-ray was obtained to assess patient lung fields due to difficulty keeping patient's oxygen saturations up.The x-ray showed a 1.1 segmental defect in the indwelling feeding tube.There was a break/discontinuity just beyond the gastroesophageal (ge) junction.The distal tube and tip were within the patient's stomach.When the feeding tube was pulled out, it was all in one piece with a clear portion of large perforation.The tube was saved and photos provided.
 
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Brand Name
CORFLO
Type of Device
TUBE, GASTROINTESTINAL
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key9344682
MDR Text Key167135146
Report Number9344682
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/07/2019,10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number40-9438
Device Catalogue Number40-9438
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2019
Event Location Hospital
Date Report to Manufacturer11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age1825 DA
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