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
container, i.v.
Product Code
KPE
Regulation Number
880.5025
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACTA MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORP.
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
EPIC MEDICAL PTE LTD
SUBSTANTIALLY EQUIVALENT
1
GILERO, LLC
SUBSTANTIALLY EQUIVALENT
1
HAEMOTRONIC S.P.A.
SUBSTANTIALLY EQUIVALENT
1
HAEMOTRONIC, SPA
SUBSTANTIALLY EQUIVALENT
1
HEALTH CARE TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC.
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VALMED S.R.L.
SUBSTANTIALLY EQUIVALENT
1
VALMED SRL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
574
574
2015
543
543
2016
527
527
2017
284
284
2018
142
157
2019
204
256
2020
147
147
2021
161
161
2022
112
112
2023
127
127
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
956
994
Device Contamination with Chemical or Other Material
926
954
Leak/Splash
240
240
Contamination /Decontamination Problem
165
165
Hole In Material
98
98
Break
92
92
Disconnection
77
77
Particulates
35
35
Detachment of Device or Device Component
35
35
Failure to Disconnect
30
31
Crack
19
19
Cut In Material
18
18
Material Separation
16
16
Material Puncture/Hole
16
16
Misassembled
16
16
Connection Problem
15
15
Material Rupture
14
14
Contamination
13
13
Device Operates Differently Than Expected
12
12
Degraded
11
11
Product Quality Problem
10
10
Material Split, Cut or Torn
10
10
Suction Problem
9
9
Tear, Rip or Hole in Device Packaging
9
9
Improper or Incorrect Procedure or Method
8
8
Loose or Intermittent Connection
8
8
Mechanical Problem
8
8
Detachment Of Device Component
8
8
Microbial Contamination of Device
7
7
Device Dislodged or Dislocated
7
7
Environmental Particulates
7
7
Defective Component
6
6
Component Falling
6
6
Air Leak
6
6
Material Discolored
6
6
Difficult to Open or Close
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
No Flow
5
5
Component Missing
5
5
Device Packaging Compromised
5
5
Defective Device
5
5
Contamination of Device Ingredient or Reagent
4
4
Device Disinfection Or Sterilization Issue
4
4
Failure to Infuse
4
4
Device Damaged Prior to Use
4
4
Decrease in Suction
4
4
Difficult to Remove
4
4
Improper Flow or Infusion
4
4
Torn Material
4
4
Component Misassembled
4
4
Manufacturing, Packaging or Shipping Problem
3
3
No Pressure
3
3
Fracture
3
3
Material Perforation
3
3
Unsealed Device Packaging
3
3
Separation Failure
3
3
Malposition of Device
2
2
Device Markings/Labelling Problem
2
2
Device Slipped
2
2
Entrapment of Device
2
2
Partial Blockage
2
2
Burst Container or Vessel
2
2
Device Difficult to Setup or Prepare
2
2
Decrease in Pressure
2
2
Kinked
2
2
Misconnection
2
2
Infusion or Flow Problem
2
2
Pressure Problem
2
2
Scratched Material
2
2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
2
2
Improper Chemical Reaction
2
2
Unexpected Color
2
2
Device Fell
2
2
Priming Problem
1
1
Separation Problem
1
1
Free or Unrestricted Flow
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Pumping Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Packaging Problem
1
1
Moisture Damage
1
1
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
Device Emits Odor
1
1
Failure to Prime
1
1
Precipitate in Device or Device Ingredient
1
1
Premature Activation
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Retraction Problem
1
1
Filling Problem
1
1
Material Fragmentation
1
1
Excess Flow or Over-Infusion
1
1
Labelling, Instructions for Use or Training Problem
1
1
Problem with Sterilization
1
1
Device Inoperable
1
1
Fitting Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Obstruction of Flow
1
1
Fail-Safe Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
1920
1974
No Clinical Signs, Symptoms or Conditions
409
409
No Known Impact Or Consequence To Patient
309
314
No Consequences Or Impact To Patient
144
152
Insufficient Information
33
33
No Information
24
24
No Code Available
4
4
Air Embolism
3
3
Death
2
2
Hypoxia
2
2
Injury
2
2
Numbness
1
1
Chemical Exposure
1
1
Weight Changes
1
1
Dysuria
1
1
Incontinence
1
1
Unspecified Infection
1
1
Nausea
1
1
Sepsis
1
1
Septic Shock
1
1
Sprain
1
1
Vomiting
1
1
Tingling
1
1
Diarrhea
1
1
Fever
1
1
Headache
1
1
Low Blood Pressure/ Hypotension
1
1
Exposure to Body Fluids
1
1
Complaint, Ill-Defined
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxa Corporation
II
Aug-02-2010
2
Baxa Corporation
II
Mar-09-2010
3
Baxter Healthcare Corp
I
Oct-31-2014
4
Baxter Healthcare Corp.
II
Apr-29-2010
5
Baxter Healthcare Corporation
II
Nov-02-2018
6
Baxter Healthcare Corporation
II
Jan-11-2018
7
Hospira Inc.
II
Sep-17-2012
8
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
9
Stradis Healthcare
II
Jan-11-2023
10
The Metrix Company
II
Oct-01-2019
11
The Metrix Company
II
Sep-29-2017
-
-