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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE
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SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE Back to Search Results
Model Number FU20AN40NSA885N
Medical Device Problem Code Material Discolored (1170)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that smiths medical trachs tubes are turning yellow at the bottom after two weeks in use.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
BIVONA
Common Device Name
TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10841041
Report Number3012307300-2020-11456
Device Sequence Number4142218
Product Code JOH
UDI-Device Identifier15019517218367
UDI-Public15019517218367
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K923878
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/02/2021
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 Lay User/Patient
Device Expiration Date09/01/2025
Device Model NumberFU20AN40NSA885N
Device Catalogue NumberFU20AN40NSA885N
Device Lot NumberSS031474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/14/2020
Supplement Date Received by Manufacturer12/02/2020
Initial Report FDA Received Date11/14/2020
Supplement Report FDA Received Date01/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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