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
container, i.v.
Product Code
KPE
Regulation Number
880.5025
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., 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
INTERNATIONAL MEDICAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VALMED SRL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
142
157
2019
204
256
2020
147
147
2021
161
161
2022
112
112
2023
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
243
281
Device Contamination with Chemical or Other Material
231
259
Contamination /Decontamination Problem
152
152
Break
39
39
Leak/Splash
30
30
Disconnection
28
28
Detachment of Device or Device Component
12
12
Degraded
9
9
Material Split, Cut or Torn
8
8
Contamination
8
8
Material Puncture/Hole
8
8
Material Rupture
7
7
Crack
7
7
Particulates
6
6
Difficult to Open or Close
6
6
Device Dislodged or Dislocated
6
6
Mechanical Problem
5
5
Component Missing
4
4
Tear, Rip or Hole in Device Packaging
3
3
Defective Component
3
3
Cut In Material
3
3
Failure to Disconnect
3
4
Defective Device
3
3
Material Separation
3
3
Material Perforation
3
3
Loose or Intermittent Connection
3
3
Fracture
3
3
Component Misassembled
3
3
Unexpected Color
2
2
Improper Flow or Infusion
2
2
Device Fell
2
2
Scratched Material
2
2
Material Integrity Problem
2
2
Hole In Material
2
2
Device Slipped
2
2
Product Quality Problem
2
2
Device Difficult to Setup or Prepare
2
2
Decrease in Pressure
2
2
Microbial Contamination of Device
2
2
Obstruction of Flow
1
1
Application Program Problem
1
1
Failure to Advance
1
1
Device Damaged Prior to Use
1
1
Entrapment of Device
1
1
Filling Problem
1
1
Burst Container or Vessel
1
1
Precipitate in Device or Device Ingredient
1
1
Premature Activation
1
1
Misassembled
1
1
Misconnection
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
No Flow
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Pressure Problem
1
1
Pumping Problem
1
1
Separation Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Fail-Safe Problem
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
380
434
No Clinical Signs, Symptoms or Conditions
274
274
No Consequences Or Impact To Patient
48
56
No Known Impact Or Consequence To Patient
43
48
Insufficient Information
27
27
No Information
9
9
Air Embolism
2
2
Hypoxia
2
2
Sprain
1
1
Exposure to Body Fluids
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Nov-02-2018
2
Baxter Healthcare Corporation
II
Jan-11-2018
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
4
Stradis Healthcare
II
Jan-11-2023
5
The Metrix Company
II
Oct-01-2019
-
-