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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 67PFS40
Medical Device Problem Codes Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the cuff on the bivona tracheostomy tube was not inflating correctly.The cuff was sticking to one side even after more sterile water was added.This issue was leading to a large air leak that was in turn creating work of breathing difficulties.No patient injury or further complications were reported in relation to this event.Additional information was requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand Name
BIVONA
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key11665298
Report Number3012307300-2021-03114
Device Sequence Number19601232
Product Code JOH
UDI-Device Identifier10351688518620
UDI-Public10351688518620
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 user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/14/2021
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 Health Professional
Device Expiration Date02/22/2023
Device Model Number67PFS40
Device Catalogue Number67PFS40
Device Lot Number3593186
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 03/17/2021
Initial Report FDA Received Date04/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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