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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD ENTERAL ACCESS DILATION SYSTEM; TUBE, GASTRO-ENTEROSTOMY
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AVANOS MEDICAL, INC. HALYARD ENTERAL ACCESS DILATION SYSTEM; TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number 98703-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Abdominal Pain (1685); Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Event Date 07/15/2019
Event Type  malfunction  
Event Description
The patient was in ir (interventional radiology) for a gj peg tube placement.During placement, md did not encounter any unusual circumstances other than a slight "catch" of the dilator as peel away sheath was separating from the device.Post procedure, the patient complained of abdominal pain.Ct scan of the abdomen revealed bowel perforation and retained foreign object.Patient was sent to or and foreign object was removed and discovered to be a part of the device that was not supposed to separate from product.
 
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Brand Name
HALYARD ENTERAL ACCESS DILATION SYSTEM
Type of Device
TUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key8944778
MDR Text Key155971605
Report Number8944778
Device Sequence Number1
Product Code KGC
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number98703-01
Device Catalogue Number98703-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Date Report to Manufacturer08/29/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age19710 DA
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