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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE
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SMITHS MEDICAL MD, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE Back to Search Results
Catalog Number CM1741N
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A report was received from the parent of an in-home patient stating the listed tracheostomy tube was found leaking at the cuff after two weeks in situ.No incident related medical sequela was reported.
 
Manufacturer Narrative
Device evaluation: one used sample was returned for evaluation.Evaluation testing found no leakage.Tube was inflated with 20cc of air and let sit for 24 hours with no noted deflation or significant dimensional change.Device operated as intended with no fault found.
 
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Brand Name
BIVONA CUSTOM TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
gary IN
Manufacturer (Section G)
SMITHS MEDICAL, INC.
5700 west 23rd ave.
gary IN 46406
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4579912
MDR Text Key18262522
Report Number2183502-2015-00092
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2015
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
Device Operator Lay User/Patient
Device Catalogue NumberCM1741N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2015
Event Location Home
Initial Date Manufacturer Received 02/16/2015
Initial Date FDA Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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