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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE Back to Search Results
Model Number 100/860/080
Device Problem Gel Leak (1267)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
It was reported that immediately after using a smiths medical portex tubes blue line ultra a leak and deflation were found.No adverse patient effects were reported.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths a tracheostomy|pvc - portex tubes blue line ultra (blu).Two pictures were received.Samples one sample from pn: 100/860/080 was received in used conditions, without its original packaging and decontaminated.No discrepancies revealed when visually inspecting device from 12" -16".The sample was given functional testing by inflating the cuff and submerging in water that revealed no bubbles or leaking came out of pilot balloon.Picture was provided.Engineering practice reviewed and revealed 100% tested and believed cause was after leaving the manufacturing.
 
Event Description
Investigation completed and summarized in h 10.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key10767168
MDR Text Key215894869
Report Number3012307300-2020-10876
Device Sequence Number1
Product Code BTO
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
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number100/860/080
Device Catalogue Number100/860/080
Device Lot Number3966330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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