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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Report source: foreign (b)(6).
 
Event Description
Information was received that a smiths medical tracheostomy suction tip valve did not stick to the proximal end of the suction channel, it fell down immediately on use.It was also reported "the red pilot of the flash to flunge cuff does not stick".No adverse patient effects were reported.
 
Manufacturer Narrative
One tracheostomy was returned for evaluation.Upon visual inspection of the device, it was confirmed that the end plug was completely missing.It was noted that the end plug and talk attachment were not returned with the sample.There was no visible adhesive remaining on the end of the airway line, and red plug for the stoma also was not adhered to the inflation line.The complaint was confirmed, however root cause is unable to be determined.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
TRACHEOSTOMY TUBE
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8139988
MDR Text Key129584665
Report Number3012307300-2018-08701
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 foreign,user facility
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Date Manufacturer Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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