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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF Back to Search Results
Model Number 101/860/075CZ
Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
One device was received for evaluation, visual inspection found the device in good condition.An inflation test was conducted by filling the cuff and leaving for 12 hours, after 12 hours the cuff was still fully inflated.Device was also put under water, and no leakage was found.Unable to confirm customer reported issue.No fault found during evaluation.Dhr could not be completed as no lot number was provided.
 
Event Description
It was reported that a smiths medical tracheostomy tube had water droplets in the cuff and leakage of air.The clinician reported difficulty adding air to the cuff.No adverse affects to patient reported.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY TUBE AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key12601562
MDR Text Key275885176
Report Number3012307300-2021-09864
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019517076141
UDI-Public15019517076141
Combination Product (y/n)N
PMA/PMN Number
K173384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101/860/075CZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received10/08/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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