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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number 100/515/080
Device Problem Component or Accessory Incompatibility (2897)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  Injury  
Event Description
Information was received that while a smiths medical tracheostomy was in use, the suction line got torn off.No patient injury resulted.
 
Manufacturer Narrative
The malfunction report was updated to a serious injury given the received information.Additional information received: the reporter stated a tracheostomy tube change out was required.
 
Manufacturer Narrative
Evaluation results: one blue line classic tracheostomy tube was returned for investigation.The returned sample was visually inspected, at a distance of 12" to 16" and normal conditions of illumination.The inspection revealed that the suction line was detached from the flange.In addition, the pilot balloon was cut from the inflation line.The most probable cause was that the manufacturing operator applied methylene chloride instead of tetrahydrofuran (thf), due to the fact that the dispensers were similar.
 
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Brand Name
PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8578333
MDR Text Key143980666
Report Number3012307300-2019-02485
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number100/515/080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2019
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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