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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBES POLAR
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBES POLAR Back to Search Results
Model Number 100/136/075
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes polar malfunctioned.No anomaly in the product was observed at a pre-use check.However, after intubating it into the patient using an airway scope, when the customer attempted to put air into it, he noticed the cuff did not inflate.Also, he heard a sound of air leakage from the pilot balloon.No patient injury.
 
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Brand Name
PORTEX
Common Device Name
TUBES POLAR
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key10298698
Report Number3012307300-2020-07433
Device Sequence Number2841813
Product Code BTR
UDI-Device Identifier15019315021329
UDI-Public15019315021329
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K931735
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/20/2020
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
Operator of Device No Information
Device Expiration Date08/01/2024
Device Model Number100/136/075
Device Catalogue Number100/136/075
Device Lot Number3852800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2020
Initial Report FDA Received Date07/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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