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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® ENDOTRACHEAL TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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SMITHS MEDICAL ASD; INC. PORTEX® ENDOTRACHEAL TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/199/070J
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
Information was received indicating that upon removal of a smiths medical portex® endotracheal tube from the patient, it was observed that the cuff was unable to be deflated.There were no reported adverse patient effects.
 
Manufacturer Narrative
One portex® endotracheal tube was returned for analysis in used conditions.Visual inspection revealed excess solvent to the inflation line to the tube.The ett was inflated with a syringe in which resistance was present to inflate or deflate the cuff.Partial occlusion was noted to the assembly of the inflation line to tube.Relevant documents were reviewed and deemed adequate.Training records and inflation line assembly operation were both reviewed; no discrepancies.The bell-out, fit inflation line and leak test operations were audited on 32 units; no discrepancies observed.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing process as the most probable causes were excess solvent or lack of detection.
 
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Brand Name
PORTEX® ENDOTRACHEAL TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9226699
MDR Text Key175063470
Report Number3012307300-2019-01255
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 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number100/199/070J
Device Lot Number3832147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Date Manufacturer Received12/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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