Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NULL PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/150/070
Device Problem Obstruction of Flow (2423)
Patient Problems Airway Obstruction (1699); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Device was not returned for investigation.
 
Event Description
It was reported that a patient with syndrome for kidney surgery, somewhat difficult respiratory, video laryngoscope used, ventilation challenges but of a smaller nature, patient was re-intubated and manages to run the anesthesia to completion.Observed kinks on tube intraorally.Patients are doing fine after the surgery.
 
Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX ENDOTRACHEAL TUBES
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section G)
NULL
MDR Report Key13359062
MDR Text Key284465529
Report Number3012307300-2022-01763
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K173912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue Number100/150/070
Device Lot Number20040370
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/21/2023
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-