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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 11/02/2018
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.
 
Manufacturer Narrative
One adult tracheostomy tube was returned for evaluation.Device underwent functional testing and a slow leak was observed on the cuff.Under magnification, a hole was found near the proximal end of the cuff.The reported customer's complaint stated the cuff had burst, these results not confirming this statement.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
 
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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
MDR Report Key8197153
MDR Text Key131426507
Report Number3012307300-2018-09033
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/17/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2019
Date Manufacturer Received01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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