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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY Back to Search Results
Model Number 100/860/070
Device Problems Material Too Rigid or Stiff (1544); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) reported malfunction by stating "the product suction line tube was stiff, and the customer had trouble connecting to the port, making it difficult to use.No patient injury.".
 
Event Description
Investigation completed and summarized in h 10.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths tracheostomy|pvc - portex tubes blue line ultra (blu).Investigation was done on /n 100/860/070 with lot number reported unknown.Visual inspection at recommended 12" to 16" and normal conditions of illumination revealed no discrepancies.During functional testing was immerged under water and no leakage was detected as the suction line of inflation is stiffer, hard but did not affect the functional of product.Quality review passed and documented at 100% before release of product.No action and no fault could be established and believed to occur after leaving smiths manufacturing.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths tracheostomy|pvc - portex tubes blue line ultra (blu).Investigation was done on /n 100/860/070 with lot number reported unknown.Visual inspection at recommended 12" to 16" and normal conditions of illumination revealed no discrepancies.During functional testing was immerged under water and no leakage was detected as the suction line of inflation is stiffer, hard but did not affect the functional of product.Quality review passed and documented at 100% before release of product.No action and no fault could be established and believed to occur after leaving smiths manufacturing.
 
Event Description
Investigation completed and summarized in h 10.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key10547624
MDR Text Key207360491
Report Number3012307300-2020-09444
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
Type of Report Initial,Followup,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number100/860/070
Device Catalogue Number100/860/070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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