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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 FT20HN40NSC066N
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/06/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a smiths medical trach tube had a leak.A trach change was needed.The trach was removed after the nurse discovered the leaking.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
Patient information and event details were provided.Information was updated.
 
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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 Key10624596
Report Number3012307300-2020-10121
Device Sequence Number2730174
Product Code JOH
UDI-Device Identifier15019517239744
UDI-Public15019517239744
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) 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date08/31/2020
Device Model NumberFT20HN40NSC066N
Device Lot NumberBS010080
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/22/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/10/2020
Supplement Date Received by Manufacturer10/13/2020
Initial Report FDA Received Date10/04/2020
Supplement Report FDA Received Date11/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age10 MO
Patient Weight8
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