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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA
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SMITHS MEDICAL ASD, INC. BIVONA Back to Search Results
Model Number 65SP050
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/18/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).
 
Event or Problem Description
Information was received indicating that a smiths medical trach one cc of air was able to be put into the pilot balloon using a syringe before the syringe "vigorously came off from it".There were no reported adverse events.
 
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
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key11047981
Report Number3012307300-2020-12624
Device Sequence Number1033933
Product Code JOH
UDI-Device Identifier15021312000320
UDI-Public15021312000320
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/24/2021
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 No Information
Device Model Number65SP050
Device Lot Number3936579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/27/2020
Supplement Date Received by Manufacturer01/24/2021
Initial Report FDA Received Date12/21/2020
Supplement Report FDA Received Date02/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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