Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
circuit, breathing (w connector, adaptor, y piece)
Product Code
CAI
Regulation Number
868.5240
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
39
39
2019
62
62
2020
71
71
2021
138
138
2022
244
244
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
130
130
Gas/Air Leak
114
114
Material Puncture/Hole
22
22
Loose or Intermittent Connection
21
21
Crack
21
21
Defective Component
20
20
Material Deformation
18
18
Disconnection
18
18
Detachment of Device or Device Component
16
16
Fitting Problem
16
16
Connection Problem
14
14
Break
13
13
Material Integrity Problem
11
11
Component Missing
10
10
Material Split, Cut or Torn
9
9
Contamination /Decontamination Problem
8
8
Inflation Problem
8
8
Tear, Rip or Hole in Device Packaging
7
7
Fluid/Blood Leak
6
6
Gas Output Problem
5
5
Obstruction of Flow
5
5
Material Twisted/Bent
4
4
Device Damaged Prior to Use
4
4
Device Slipped
4
4
Fracture
4
4
Product Quality Problem
4
4
Pressure Problem
4
4
Insufficient Information
4
4
Appropriate Term/Code Not Available
3
3
Separation Problem
3
3
Air/Gas in Device
3
3
Delivered as Unsterile Product
3
3
Shipping Damage or Problem
3
3
Inadequacy of Device Shape and/or Size
3
3
Misconnection
3
3
Material Fragmentation
3
3
Incomplete or Missing Packaging
3
3
Defective Device
3
3
Device Displays Incorrect Message
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Device Operates Differently Than Expected
3
3
Infusion or Flow Problem
2
2
Blocked Connection
2
2
Failure to Deliver
2
2
Microbial Contamination of Device
2
2
Improper or Incorrect Procedure or Method
2
2
Loss of or Failure to Bond
2
2
Material Perforation
2
2
Complete Blockage
2
2
Device Alarm System
2
2
Deflation Problem
2
2
Material Discolored
2
2
Mechanical Problem
2
2
Occlusion Within Device
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Too Rigid or Stiff
2
2
Unintended Deflation
2
2
Physical Resistance/Sticking
2
2
No Flow
2
2
No Pressure
2
2
Packaging Problem
1
1
Power Problem
1
1
Noise, Audible
1
1
Therapeutic or Diagnostic Output Failure
1
1
Misassembly by Users
1
1
Premature Separation
1
1
Unexpected Color
1
1
Material Separation
1
1
Decrease in Pressure
1
1
Melted
1
1
Moisture Damage
1
1
Difficult to Insert
1
1
Decoupling
1
1
Defective Alarm
1
1
Partial Blockage
1
1
Hole In Material
1
1
Material Disintegration
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Fire
1
1
Insufficient Flow or Under Infusion
1
1
Tidal Volume Fluctuations
1
1
Use of Device Problem
1
1
Deformation Due to Compressive Stress
1
1
Improper Flow or Infusion
1
1
Compatibility Problem
1
1
Moisture or Humidity Problem
1
1
Difficult to Open or Close
1
1
Failure of Device to Self-Test
1
1
Device Markings/Labelling Problem
1
1
Failure to Disconnect
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
337
337
No Patient Involvement
73
73
No Consequences Or Impact To Patient
50
50
No Known Impact Or Consequence To Patient
33
33
Insufficient Information
22
22
Hypoxia
7
7
Low Oxygen Saturation
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Respiratory Distress
6
6
No Information
4
4
Foreign Body In Patient
2
2
Hypoventilation
2
2
Viral Infection
2
2
Bacterial Infection
2
2
Burn(s)
1
1
Cardiopulmonary Arrest
1
1
Death
1
1
Dyspnea
1
1
Pain
1
1
Apnea
1
1
Aspiration/Inhalation
1
1
Extubate
1
1
Irritability
1
1
Respiratory Failure
1
1
Decreased Respiratory Rate
1
1
Electric Shock
1
1
Chemical Exposure
1
1
Patient Problem/Medical Problem
1
1
Respiratory Distress Syndrome of Newborns
1
1
Swelling
1
1
No Code Available
1
1
Balance Problems
1
1
Test Result
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Intersurgical Inc
II
Jun-27-2018
2
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
3
Medline Industries Inc
II
Dec-18-2019
-
-