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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/150/065
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.The product was returned and visual testing was performed no damages were detected on the samples.The reported issue could not be determined since the complaint was not confirmed due to the fact the accuracy test was successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that after intubation and inflation of the cuff, no external visibility of the state of inflation of the cuff because the external cuff could not be inflated.No patient injury reported.
 
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Brand Name
PORTEX ENDOTRACHEAL TUBES
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15443270
MDR Text Key306169294
Report Number3012307300-2022-19567
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 Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/18/2022
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 Catalogue Number100/150/065
Device Lot Number19090265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/21/2022
Initial Date FDA Received09/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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