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: TELEFLEX MEDICAL HUDSON TRACH-VENT+,CLEAN; CONDENSER, HEAT AND MOISTURE
  • 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
 

TELEFLEX MEDICAL HUDSON TRACH-VENT+,CLEAN; CONDENSER, HEAT AND MOISTURE Back to Search Results
Catalog Number G41312
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges, "it was reported that the user found the connection port came off and fell into the cannula during use." the report states that the device was replaced.No harm or injury to the patient reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the silicone valve was detached.The complaint reports that the user found the connection port came off and fell into the cannula during use.This may happen as a result of mishandling during use of the product.In the current manufacturing procedure, a 100% visual inspection is done at the assembly area, thus, any defective products would be detected at that time.
 
Event Description
Customer complaint alleges, "it was reported that the user found the connection port came off and fell into the cannula during use." the report states that the device was replaced.No harm or injury to the patient reported.Patient condition reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON TRACH-VENT+,CLEAN
Type of Device
CONDENSER, HEAT AND MOISTURE
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL
po box 28, kamunting industrial estate
perak, west malaysia 34600
MY   34600
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6280631
MDR Text Key65852526
Report Number8040412-2017-00015
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/05/2017
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 No Information
Device Catalogue NumberG41312
Device Lot Number201624J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2017
Initial Date FDA Received01/26/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-