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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX; ENDOTRACHEAL TUBE
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NULL PORTEX; ENDOTRACHEAL TUBE Back to Search Results
Catalog Number 100/150/085
Device Problems Failure to Disconnect (2541); Material Deformation (2976)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that when the patient was intubated, the valve ?withered" by itself.It was not possible to segregate the material.No additional information available.
 
Manufacturer Narrative
Other, other text: the sample was not received for investigation.The customer reported issue could not be confirmed due to no receipt of photos or actual sample for investigation.This is a supplied item; the device history record (dhr) is at the supplier.The root cause for the reported issue could not be determined.If the product is returned at a later date, a summary of the investigation results will be provided in a supplemental report.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
 
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Brand Name
PORTEX
Type of Device
ENDOTRACHEAL TUBE
Manufacturer (Section G)
NULL
MDR Report Key10648453
MDR Text Key210387021
Report Number3012307300-2020-10230
Device Sequence Number1
Product Code CBI
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number100/150/085
Device Lot Number19022785
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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