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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRACHEOSTOMY
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TRACHEOSTOMY Back to Search Results
Catalog Number 100/860/090
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that during use of a smiths medical tracheostomy|pvc - portex tube blue line ultra (blu), it was noted that the customer noticed the suction line got detached.No patient consequences were reported.No adverse effects were reported.
 
Manufacturer Narrative
Device evaluation results: one portex tracheostomy tube was returned for investigation used condition.The returned sample was visually inspected at 12 to 16 inches and under normal conditions of illumination.The suction line was detached.The customer reported product problem was therefore confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.
 
Manufacturer Narrative
Other, other text: h10 ? device evaluation results: one portex tracheostomy tube was returned for investigation used condition.The returned sample was visually inspected at 12 to 16 inches and under normal conditions of illumination.The suction line was detached.The customer reported product problem was therefore confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.
 
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Brand Name
TRACHEOSTOMY
MDR Report Key10612619
MDR Text Key210376592
Report Number3012307300-2020-10003
Device Sequence Number1
Product Code BSY
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number100/860/090
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/18/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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