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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  Injury  
Event Description
Information was received indicating that two months following use of a smiths medical portex® bivona® adult tts¿ tracheostomy tube, the cuff was reported to burst.It was reported that upon testing the cuff, it was noted that it could not hold 6cc without leaking.Subsequently, a tracheostomy (trach) tube change out was performed with no adverse patient effects.
 
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Brand Name
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key8197824
MDR Text Key131443320
Report Number3012307300-2018-09045
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/27/2018
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
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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