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TPLC
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Device
stopcock, i.v. set
Product Code
FMG
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DYNAREX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ELCAM MEDICAL ACAL
SUBSTANTIALLY EQUIVALENT
2
M/S ROMSONS INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
MONUMEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
YOMURA TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
164
166
2019
400
414
2020
284
284
2021
245
245
2022
280
280
2023
390
390
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
620
636
Leak/Splash
452
452
Disconnection
165
167
Crack
111
111
Device Contamination with Chemical or Other Material
107
107
Break
93
93
Loose or Intermittent Connection
55
55
Air/Gas in Device
52
52
Connection Problem
51
51
No Flow
45
45
Particulates
43
43
Infusion or Flow Problem
40
40
Detachment of Device or Device Component
38
38
Material Separation
26
26
Backflow
23
23
Obstruction of Flow
16
16
Defective Component
14
14
Gas/Air Leak
13
13
Packaging Problem
13
13
Physical Resistance/Sticking
13
13
Complete Blockage
12
12
Contamination
10
10
Fracture
9
9
Material Twisted/Bent
9
9
Defective Device
9
9
Free or Unrestricted Flow
8
8
Improper Flow or Infusion
7
7
Contamination /Decontamination Problem
7
7
Excess Flow or Over-Infusion
7
7
Mechanical Problem
7
7
Delivered as Unsterile Product
7
7
Device Markings/Labelling Problem
6
6
Inaccurate Delivery
6
6
Material Split, Cut or Torn
6
6
Separation Problem
5
5
Unsealed Device Packaging
5
5
Failure to Deliver
4
4
Insufficient Flow or Under Infusion
4
4
Retraction Problem
4
4
Failure to Prime
4
4
Inaccurate Flow Rate
4
4
Flushing Problem
4
4
Incomplete or Inadequate Connection
4
4
Detachment Of Device Component
3
3
Material Puncture/Hole
3
3
Device Damaged Prior to Use
3
3
Failure to Disconnect
3
3
Material Protrusion/Extrusion
3
3
Mechanical Jam
3
3
Material Deformation
3
3
Material Integrity Problem
2
2
Separation Failure
2
2
Dent in Material
2
2
Microbial Contamination of Device
2
2
Reflux within Device
2
2
Improper or Incorrect Procedure or Method
2
2
Burst Container or Vessel
2
2
Filling Problem
2
2
Device Fell
2
2
Protective Measures Problem
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
1
1
Component Misassembled
1
1
Temperature Problem
1
1
Unintended Movement
1
1
Positioning Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Priming Problem
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Missing Information
1
1
Wrong Label
1
1
Unintended Ejection
1
1
Material Discolored
1
1
Component Falling
1
1
Partial Blockage
1
1
Loss of or Failure to Bond
1
1
Air Leak
1
1
Defective Alarm
1
1
Suction Problem
1
1
Material Rupture
1
1
Increase in Pressure
1
1
Occlusion Within Device
1
1
Material Opacification
1
1
Pacing Problem
1
1
Kinked
1
1
Material Fragmentation
1
1
Component Missing
1
1
Failure to Infuse
1
1
Tear, Rip or Hole in Device Packaging
1
1
Expiration Date Error
1
1
Structural Problem
1
1
Blocked Connection
1
1
Deformation Due to Compressive Stress
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
738
738
No Consequences Or Impact To Patient
368
380
No Known Impact Or Consequence To Patient
347
351
Chemical Exposure
120
120
No Patient Involvement
75
75
Insufficient Information
64
64
Low Blood Pressure/ Hypotension
56
56
No Information
38
38
Blood Loss
25
25
Hemorrhage/Bleeding
15
15
Air Embolism
8
8
Cardiac Arrest
7
7
Awareness during Anaesthesia
5
5
Death
5
5
Hypoglycemia
4
4
Missed Dose
4
4
Low Oxygen Saturation
3
3
High Blood Pressure/ Hypertension
3
3
Nausea
3
3
Sepsis
3
3
Tachycardia
2
2
Hypovolemia
2
2
Malaise
2
2
Unspecified Infection
2
2
Emotional Changes
2
2
Stroke/CVA
2
2
Headache
2
2
Exposure to Body Fluids
2
2
Underdose
2
2
Discomfort
2
2
Burning Sensation
2
2
Loss of consciousness
2
2
No Code Available
2
2
Skin Burning Sensation
2
2
Unintended Radiation Exposure
1
1
Patient Problem/Medical Problem
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Blister
1
1
Loss Of Pulse
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Confusion/ Disorientation
1
1
Respiratory Failure
1
1
Increased Respiratory Rate
1
1
Bradycardia
1
1
Cardiopulmonary Arrest
1
1
Pulmonary Embolism
1
1
Radiation Overdose
1
1
Hyperglycemia
1
1
Erythema
1
1
Exsanguination
1
1
Infiltration into Tissue
1
1
Laceration(s)
1
1
Overdose
1
1
Phlebitis
1
1
Hypoxia
1
1
Inadequate Pain Relief
1
1
Ventilator Dependent
1
1
Extubate
1
1
Cardiogenic Shock
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Jul-21-2022
2
ICU Medical de Mexico, S.A. de C.V.
II
Aug-16-2018
3
ICU Medical, Inc.
II
Sep-09-2022
4
ICU Medical, Inc.
II
Feb-05-2021
5
ICU Medical, Inc.
II
Dec-01-2020
6
ICU Medical, Inc.
II
May-06-2020
7
ICU Medical, Inc.
II
Oct-04-2018
8
ICU Medical, Inc.
II
Aug-07-2018
9
ICU Medical, Inc.
II
Apr-10-2018
10
Smiths Medical ASD Inc.
II
Oct-20-2021
11
Smiths Medical ASD Inc.
II
Jul-05-2019
12
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
II
Feb-21-2018
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