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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE AND TUBE CUFF Back to Search Results
Model Number 67PFPS45
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device cuff would not inflate.No patient involvement.
 
Additional Manufacturer Narrative
Other, other text: 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 AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key11167332
Report Number3012307300-2021-00393
Device Sequence Number3718260
Product Code JOH
UDI-Device Identifier10351688518552
UDI-Public10351688518552
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K923878
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/27/2021
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 Model Number67PFPS45
Device Catalogue Number67PFPS45
Device Lot Number3965904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/15/2020
Supplement Date Received by Manufacturer01/31/2021
Initial Report FDA Received Date01/13/2021
Supplement Report FDA Received Date02/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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