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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
95
95
2017
34
34
2018
9
9
2019
9
9
2020
92
92
2021
109
109
2022
21
21
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
180
180
No Flow
92
92
Break
30
30
Leak/Splash
28
28
Obstruction of Flow
22
22
Device Operates Differently Than Expected
21
21
Infusion or Flow Problem
17
17
Occlusion Within Device
17
17
Device Contamination with Chemical or Other Material
13
13
Defective Device
12
12
Fluid/Blood Leak
12
12
Material Separation
9
9
Restricted Flow rate
8
8
Device Damaged Prior to Use
7
7
Detachment Of Device Component
7
7
Disconnection
7
7
Crack
7
7
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
7
7
Material Integrity Problem
6
6
Improper Flow or Infusion
6
6
Fracture
6
6
Partial Blockage
5
5
Delivered as Unsterile Product
5
5
Improper Device Output
4
4
Connection Problem
4
4
Tear, Rip or Hole in Device Packaging
3
3
Measurement System Incompatibility
3
3
Product Quality Problem
3
3
Defective Component
3
3
Contamination /Decontamination Problem
3
3
Biofilm coating in Device
3
3
Collapse
3
3
Material Fragmentation
2
2
Use of Device Problem
2
2
Insufficient Flow or Under Infusion
2
2
Component Missing
2
2
Unsealed Device Packaging
2
2
Device Packaging Compromised
2
2
Difficult to Open or Close
1
1
Device Contamination With Biological Material
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Contaminated During Manufacture or Shipping
1
1
Temperature Problem
1
1
Unintended Deflation
1
1
Positioning Problem
1
1
Shipping Damage or Problem
1
1
Device Inoperable
1
1
Out-Of-Box Failure
1
1
Hole In Material
1
1
Kinked
1
1
Filling Problem
1
1
Contamination
1
1
Decoupling
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
215
215
No Clinical Signs, Symptoms or Conditions
133
133
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
Tissue Damage
4
4
Rupture
4
4
No Information
4
4
Foreign Body In Patient
4
4
Discomfort
3
3
Obstruction/Occlusion
2
2
Abdominal Distention
2
2
Confusion/ Disorientation
1
1
Dyspnea
1
1
Micturition Urgency
1
1
Urinary Tract Infection
1
1
Burning Sensation
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
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