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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. KIT 20FR 16FR POLYURETHANE LOW PROFILE SYRINGE DILATOR INTRODUCER GASTROSTOMY MI TUBE, GASTRO-ENTEROSTOMY

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AVANOS MEDICAL INC. KIT 20FR 16FR POLYURETHANE LOW PROFILE SYRINGE DILATOR INTRODUCER GASTROSTOMY MI TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number 98432
Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)
Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Event Date 04/03/2020
Event Type  Injury  
Event Description
Gj tube placed for gastroparesis. Individual dilators used to dilate the tract for the tube. Then used the telescoping dilator/peel away sheath that came with the gj tube kit to feed the tube through. The telescoping dilator is one intact piece that contains dilators of multiple sizes. When dilators removed as one unit, the peel away sheath was left in place. Difficulty getting the gj tube through the sheath - the peel away sheath was changed to a larger peel away sheath. The gj tube went through the larger peel away sheath without any difficulty. At the conclusion of the procedure, the gastric portion of the tube was positioned in the stomach and the jejunal portion of the tube was in the small bowel. The patient presented to the ed 6 days later with rlq pain. A ct suggested a foreign body in the abdomen which caused a perforation. Surgery confirmed it was a piece of the telescoping dilator. The telescoping dilator should have never come apart and is likely an equipment failure. Due to the design of the telescoping dilator and the fact that all of the dilators collapse on one another, we would not know that a piece of it had detached during the procedure. The telescoping dilator is radiolucent, which means there was no way to visualize the dilator in the gi tract during the procedure that we performed. Fda safety report id# (b)(4).
 
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Brand NameKIT 20FR 16FR POLYURETHANE LOW PROFILE SYRINGE DILATOR INTRODUCER GASTROSTOMY MI
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
AVANOS MEDICAL INC.
MDR Report Key9995052
MDR Text Key189164477
Report NumberMW5094247
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number98432
Device Catalogue Number98432-03
Device Lot NumberAA9196N07
Was Device Available for Evaluation? Yes
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: 04/23/2020 Patient Sequence Number: 1
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