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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 67NFPS35
Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2023
Event Type  malfunction  
Event Description
Known issues: event 1: 1 device ¿ cuff wouldn¿t inflate at all prior to use.Not reprocessed.(unfortunately, that product was thrown away by provider).Event 2: 2 devices ¿ were used and reprocessed, but now have a lopsided cuff (looks like a bulge in a tire), which creates issues with the seal against the tracheal wall (cannot easily ventilate with a leak).Unknown if this was how the trach was before reprocessing.Reprocessed less than 5 times.Event 3: 1 device ¿ inverted bell-shaped cuff with cuff not inflating well towards the bottom, with a more rounded top.
 
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Brand Name
BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
MDR Report Key16494923
MDR Text Key310786774
Report Number16494923
Device Sequence Number1
Product Code JOH
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 02/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number67NFPS35
Device Catalogue Number67NFPS35
Device Lot Number433426
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2023
Event Location Hospital
Date Report to Manufacturer03/07/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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