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TPLC
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Device
container, i.v.
Regulation Description
I.V. container.
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
EPIC MEDICAL PTE 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
MDR Year
MDR Reports
MDR Events
2020
147
147
2021
161
161
2022
112
112
2023
127
127
2024
158
158
2025
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
245
245
Device Contamination with Chemical or Other Material
195
195
Contamination /Decontamination Problem
121
121
Detachment of Device or Device Component
38
38
Break
31
31
Leak/Splash
30
30
Disconnection
26
26
Material Puncture/Hole
18
18
Mechanical Problem
12
12
Material Split, Cut or Torn
11
11
Contamination
10
10
Degraded
9
9
Crack
8
8
Material Separation
7
7
Air/Gas in Device
7
7
Particulates
6
6
Device Dislodged or Dislocated
6
6
Material Rupture
5
5
Difficult to Open or Close
5
5
Defective Component
5
5
Contamination of Device Ingredient or Reagent
4
4
Component Missing
4
4
Component Misassembled
4
4
Fracture
3
3
No Flow
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Microbial Contamination of Device
2
2
Defective Device
2
2
Scratched Material
2
2
Device Difficult to Setup or Prepare
2
2
Incomplete or Inadequate Connection
2
2
Improper Flow or Infusion
2
2
Decrease in Pressure
2
2
Tear, Rip or Hole in Device Packaging
2
2
Product Quality Problem
2
2
Unexpected Color
2
2
No Apparent Adverse Event
1
1
Failure to Advance
1
1
Free or Unrestricted Flow
1
1
Protective Measures Problem
1
1
Priming Problem
1
1
Loose or Intermittent Connection
1
1
Failure to Disconnect
1
1
Premature Activation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Deformation
1
1
Delivered as Unsterile Product
1
1
Infusion or Flow Problem
1
1
Material Perforation
1
1
Obstruction of Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
610
610
No Patient Involvement
103
103
Insufficient Information
46
46
No Consequences Or Impact To Patient
18
18
No Known Impact Or Consequence To Patient
13
13
Air Embolism
2
2
Chemical Exposure
2
2
Hypoxia
2
2
Exposure to Body Fluids
1
1
Awareness during Anaesthesia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
2
Microtek Medical Inc.
II
Aug-16-2024
3
ROi CPS LLC
II
Aug-16-2024
4
Stradis Healthcare
II
Jan-11-2023
5
The Metrix Company
II
Nov-08-2024
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