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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INC. BIVONA CUSTOMER TRACHEOSTOMY TUBE
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SMITHS MEDICAL INC. BIVONA CUSTOMER TRACHEOSTOMY TUBE Back to Search Results
Catalog Number CM174IN
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 pt stating the listed tracheostomy tube was found leaking at the cuff after one month in situ.No incident related medical sequela was reported.
 
Manufacturer Narrative
Customer has not yet returned the device to the mfr for device evaluation.When and if the device becomes available and is returned and evaluated, the mfr will file a follow-up report detailing the results of the evaluation.
 
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Brand Name
BIVONA CUSTOMER TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL INC.
gary IN
Manufacturer (Section G)
SMITHS MEDICAL INC.
5700 w 23rd ave
gary IN 46406
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4486415
MDR Text Key5344640
Report Number2183502-2014-01106
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Lay User/Patient
Type of Report Initial
Report Date 01/27/2015
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 NumberCM174IN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2015
Event Location Home
Initial Date Manufacturer Received 01/06/2015
Initial Date FDA Received01/28/2015
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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