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: PORTEX; TRACHEOSTOMY
  • 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
 

PORTEX; TRACHEOSTOMY Back to Search Results
Model Number 101/860/085CZ
Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information received a smiths medical tracheostomy|pvc - portex tubes bluselect malfunctioned.The customer confirmed that the product worked properly in a pre-use check.However, during the use of the product, the customer noticed the inflation line got detached from the pilot balloon.No patient injury.
 
Manufacturer Narrative
Other, other text: one used decontaminated sample 10009163-005 8.5mm deht blu suctionaid sub-assy was received in plastic bag without its original packaging (see photo of sample).Under visual inspection we noticed that pilot balloon was detached from inflation line.10001429-005 infl.Line s/assy soft-seal 8.5mm is assembled in smiths medical tijuana therefore secondary investigation object in-0099123 was created and complaint sample was resent to this site.
 
Event Description
Investigation completed and summary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX
Type of Device
TRACHEOSTOMY
MDR Report Key11387139
MDR Text Key233826828
Report Number3012307300-2021-01599
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019517076165
UDI-Public15019517076165
Combination Product (y/n)N
PMA/PMN Number
K173384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number101/860/085CZ
Device Catalogue Number101/860/085CZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-