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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number SU20HN35NGF965N
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/27/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the bivona tracheostomy tube was broken.This was observed when the dressing was being changed on the respirator dependent patient.The patient had a history of the following: chronic respiratory failure, unspecified with hypoxia or hypercapnia, dysphagia (unspecified) congenital malformation (unspecified), congenital tracheo-esophageal fistula without atresia, and acute kidney failure (unspecified).No patient injury or complications were reported in relation to this event.The event was described as resolved.The affected bivona tracheostomy tube was discarded.
 
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Brand Name
BIVONA
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10935907
Report Number3012307300-2020-12015
Device Sequence Number2322496
Product Code JOH
UDI-Device Identifier15019517238174
UDI-Public15019517238174
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K923878
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/02/2020
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
Operator of Device No Information
Device Model NumberSU20HN35NGF965N
Device Catalogue NumberSU20HN35NGF965N
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2020
Initial Report FDA Received Date12/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age27 MO
Patient Weight8
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