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TPLC
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show TPLC since
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Device
device, urine flow rate measuring, non-electrical, disposable
Product Code
FFG
Regulation Number
876.1800
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
54
54
2015
102
102
2016
96
96
2017
34
34
2018
9
9
2019
9
9
2020
92
92
2021
109
109
2022
21
21
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
180
180
No Flow
92
92
Break
31
31
Leak/Splash
28
28
Obstruction of Flow
22
22
Device Operates Differently Than Expected
21
21
Infusion or Flow Problem
18
18
Occlusion Within Device
17
17
Device Contamination with Chemical or Other Material
13
13
Fluid/Blood Leak
12
12
Defective Device
12
12
Material Separation
9
9
Restricted Flow rate
8
8
Detachment Of Device Component
7
7
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
7
7
Device Damaged Prior to Use
7
7
Crack
7
7
Disconnection
7
7
Material Integrity Problem
6
6
Fracture
6
6
Improper Flow or Infusion
6
6
Partial Blockage
5
5
Delivered as Unsterile Product
5
5
Connection Problem
4
4
Improper Device Output
4
4
Tear, Rip or Hole in Device Packaging
3
3
Product Quality Problem
3
3
Collapse
3
3
Measurement System Incompatibility
3
3
Defective Component
3
3
Contamination /Decontamination Problem
3
3
Biofilm coating in Device
3
3
Insufficient Flow or Under Infusion
2
2
Unsealed Device Packaging
2
2
Material Fragmentation
2
2
Use of Device Problem
2
2
Device Packaging Compromised
2
2
Component Missing
2
2
Decoupling
1
1
Device Disinfection Or Sterilization Issue
1
1
Difficult or Delayed Positioning
1
1
Out-Of-Box Failure
1
1
Filling Problem
1
1
Kinked
1
1
Unintended Deflation
1
1
Shipping Damage or Problem
1
1
Positioning Problem
1
1
Device Contamination With Biological Material
1
1
Device Inoperable
1
1
Difficult to Open or Close
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
216
216
No Clinical Signs, Symptoms or Conditions
135
135
No Consequences Or Impact To Patient
89
89
No Patient Involvement
46
46
Urinary Retention
24
24
Insufficient Information
19
19
Missing Value Reason
7
7
Pain
5
5
No Information
4
4
Rupture
4
4
Foreign Body In Patient
4
4
Tissue Damage
4
4
Discomfort
3
3
Abdominal Distention
2
2
Obstruction/Occlusion
2
2
Confusion/ Disorientation
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Burning Sensation
1
1
Micturition Urgency
1
1
Dyspnea
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
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