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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE
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SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE Back to Search Results
Model Number FF18JN60ZTA113N
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/10/2021
Type of Reportable Event Malfunction
Event or Problem Description
A patient called and stated that the parent was unable to disconnect a ventilator circuit from the tracheostomy tube.Two ccns attended the home and in the end as they were also unable to disconnect it, they carried out an emergency tube change.The end of the trach was wedged into the swivel elbow.The top tracheostomy in the picture is just to show the part that came away.The tube was changed 2 weeks ago.It was still in the recommended timeframe for changing the tube.
 
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Brand Name
BIVONA
Common Device Name
TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key11579463
Report Number3012307300-2021-02534
Device Sequence Number11875882
Product Code JOH
UDI-Device Identifier15019517168983
UDI-Public15019517168983
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFF18JN60ZTA113N
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 02/11/2021
Initial Report FDA Received Date03/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age8 YR
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