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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number ZU18FN50NZZ105NZ
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
 
Event or Problem Description
It was reported that the dimensions of the bivona customer tube were in correct.The following issues were noted: length 60mm instead of 50mm, thickening at the level of the fenestration (8.0 instead of 7.3 mm).No patient complications were reported in connection with this incident.
 
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Brand Name
BIVONA TRACHEOSTOMY TUBE
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7736832
Report Number3012307300-2018-03213
Device Sequence Number2771619
Product Code JOH
UDI-Device Identifier15019517155860
UDI-Public15019517155860
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K923878
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/31/2018
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 Expiration Date06/22/2023
Device Catalogue NumberZU18FN50NZZ105NZ
Device Lot NumberDS017732
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2018
Initial Report FDA Received Date07/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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