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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
set, tubing, blood, with and without anti-regurgitation valve
Product Code
FJK
Regulation Number
876.5820
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD
SUBSTANTIALLY EQUIVALENT
1
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
DIMESOL, INC.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
JIANGXI SANXIN MEDTEC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OUTSET MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
131
131
2018
119
119
2019
185
185
2020
190
190
2021
188
188
2022
362
362
2023
585
585
2024
282
282
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
869
869
Leak/Splash
370
370
Air/Gas in Device
292
292
Detachment of Device or Device Component
196
196
Material Puncture/Hole
179
179
Adverse Event Without Identified Device or Use Problem
90
90
Disconnection
60
60
Crack
54
54
Loose or Intermittent Connection
37
37
Contamination /Decontamination Problem
30
30
Obstruction of Flow
23
23
Break
20
20
Material Deformation
16
16
Connection Problem
12
12
Material Separation
10
10
Air Leak
10
10
Degraded
10
10
Material Split, Cut or Torn
9
9
Separation Problem
9
9
No Fail-Safe Mechanism
8
8
Defective Component
7
7
Insufficient Information
7
7
Device Dislodged or Dislocated
6
6
Device Contamination with Chemical or Other Material
6
6
Improper or Incorrect Procedure or Method
5
5
Gas/Air Leak
5
5
Inadequate Filtration Process
5
5
Hole In Material
5
5
Material Rupture
4
4
Component Missing
4
4
Occlusion Within Device
4
4
Device Displays Incorrect Message
4
4
Material Perforation
3
3
Device Alarm System
3
3
Improper Flow or Infusion
3
3
Device Operates Differently Than Expected
3
3
Pressure Problem
3
3
Migration or Expulsion of Device
3
3
Output Problem
3
3
No Audible Alarm
2
2
Failure To Adhere Or Bond
2
2
Split
2
2
Device Slipped
2
2
Protective Measures Problem
2
2
Detachment Of Device Component
2
2
Loss of Power
2
2
No Flow
2
2
Device Operational Issue
2
2
Defective Device
2
2
Failure of Device to Self-Test
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
939
939
Hemorrhage/Bleeding
393
393
No Known Impact Or Consequence To Patient
379
379
Blood Loss
82
82
No Consequences Or Impact To Patient
72
72
Low Blood Pressure/ Hypotension
42
42
Insufficient Information
34
34
Hemolysis
32
32
Cardiac Arrest
30
30
Death
25
25
Loss of consciousness
24
24
Dyspnea
16
16
Exsanguination
15
15
Anemia
13
13
Hypovolemia
12
12
Cardiopulmonary Arrest
12
12
Chest Pain
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Hypersensitivity/Allergic reaction
8
8
No Patient Involvement
8
8
Dizziness
8
8
Nausea
6
6
Syncope
5
5
Confusion/ Disorientation
5
5
Low Oxygen Saturation
4
4
Bradycardia
4
4
Cramp(s) /Muscle Spasm(s)
4
4
Abdominal Pain
4
4
Itching Sensation
4
4
High Blood Pressure/ Hypertension
4
4
Syncope/Fainting
4
4
No Code Available
4
4
Air Embolism
3
3
Foreign Body In Patient
3
3
Vomiting
3
3
Diaphoresis
3
3
Hypervolemia
2
2
Pulmonary Embolism
2
2
Decreased Respiratory Rate
2
2
Unspecified Infection
2
2
Convulsion/Seizure
2
2
Hypoxia
2
2
Sudden Cardiac Death
2
2
Anxiety
2
2
Congestive Heart Failure
2
2
Hyperthermia
2
2
Seizures
2
2
Loss Of Pulse
2
2
Weakness
2
2
Hemolytic Anemia
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Sep-19-2024
2
Baxter Healthcare Corporation
II
May-26-2021
3
Baxter Healthcare Corporation
II
Feb-16-2021
4
Baxter Healthcare Corporation
II
Jun-01-2020
5
ICU Medical, Inc.
II
Dec-23-2020
6
Nipro Medical Corporation
II
May-15-2018
-
-