• 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 COMFORT FLO PLUS CANNULA W/CHIN STRAP-S; NASAL OXYGEN CANNULA

  • 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 COMFORT FLO PLUS CANNULA W/CHIN STRAP-S; NASAL OXYGEN CANNULA Back to Search Results
Catalog Number 2412-13
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device sample was not returned for evaluation at the time of this report.
 
Event Description
The customer alleges that two pin hole leaks were found in the comfort flow plus cannula.No patient injury reported.
 
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 not returned for evaluation.Since the actual sample was not returned, ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect.The samples were all visually inspected and no issues were observed.In addition, leak testing was also performed on all ten samples, and no leaks were detected.Because no sample was returned, the complaint could not be confirmed.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release.
 
Event Description
The customer alleges that two pin hole leaks were found in the comfort flow plus cannula.No patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S
Type of Device
NASAL OXYGEN CANNULA
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 carringtin mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5822906
MDR Text Key50464286
Report Number8040412-2016-00152
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2412-13
Device Lot Number201615
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-