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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BIVONA TRACHEOSTOMY TUBE, ADULT?; TUBE TRACHEOSTOMY AND TUBE CUFF
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NULL BIVONA TRACHEOSTOMY TUBE, ADULT?; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2021
Event Type  Injury  
Event Description
It was reported that there was currently a special tracheostomy cannula that must be emptied with a special syringe.During the day the cuff was increasingly leaking, the customer was unable to solve the issue.The customer troubleshooted the switch, by putting the needle over a suction cat repeatedly.The customer tried to empty the cuff to get the needle out, however it could not be emptied so it could get out through stomach.The needle was not displaced in the trachea, it filled a little more air in the cuff and the cuff was tight.It failed to switch.The needle was changed later the next day on the operating room.The reported issue required a medical or surgical treatment.
 
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Brand Name
BIVONA TRACHEOSTOMY TUBE, ADULT?
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section G)
NULL
MDR Report Key13392621
MDR Text Key284697051
Report Number3012307300-2022-02186
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2022
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 Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/03/2022
Initial Date FDA Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age49 YR
Patient SexMale
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