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TPLC
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Device
collector, urine, (and accessories) for indwelling catheter
Product Code
KNX
Regulation Number
876.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
235
235
2020
215
215
2021
209
209
2022
167
167
2023
178
178
2024
122
122
Device Problems
MDRs with this Device Problem
Events in those MDRs
Restricted Flow rate
417
417
Deformation Due to Compressive Stress
142
142
Component Missing
69
69
Component Misassembled
57
57
Material Twisted/Bent
56
56
Fluid/Blood Leak
49
49
Obstruction of Flow
49
49
No Flow
47
47
Partial Blockage
27
27
Adverse Event Without Identified Device or Use Problem
27
27
Physical Resistance/Sticking
27
27
Device Contamination with Chemical or Other Material
26
26
Deflation Problem
25
25
Leak/Splash
23
23
Disconnection
21
21
Material Deformation
20
20
Detachment of Device or Device Component
18
18
Biocompatibility
17
17
Infusion or Flow Problem
16
16
Inaccurate Flow Rate
15
15
Improper Flow or Infusion
14
14
Material Fragmentation
14
14
Difficult to Open or Close
12
12
Backflow
12
12
Nonstandard Device
11
11
Expiration Date Error
9
9
Use of Device Problem
9
9
Complete Blockage
8
8
Therapeutic or Diagnostic Output Failure
8
8
Device Markings/Labelling Problem
7
7
Device Handling Problem
7
7
Break
7
7
Difficult to Remove
7
7
Incorrect Measurement
6
6
Patient-Device Incompatibility
6
6
Misassembled
6
6
Unintended Deflation
6
6
Material Split, Cut or Torn
6
6
Inadequate Instructions for Healthcare Professional
6
6
Suction Problem
6
6
Patient Device Interaction Problem
6
6
Appropriate Term/Code Not Available
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Defective Device
5
5
Short Fill
5
5
Material Too Rigid or Stiff
4
4
Difficult to Open or Remove Packaging Material
4
4
Illegible Information
4
4
Material Puncture/Hole
4
4
Fracture
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
598
598
No Consequences Or Impact To Patient
312
312
No Known Impact Or Consequence To Patient
233
233
No Patient Involvement
73
73
Urinary Tract Infection
54
54
Pain
29
29
Unspecified Infection
22
22
Urinary Retention
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
17
17
Discomfort
16
16
Insufficient Information
12
12
Patient Problem/Medical Problem
6
6
No Code Available
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Hematuria
4
4
No Information
4
4
Skin Inflammation/ Irritation
4
4
Micturition Urgency
4
4
Foreign Body In Patient
4
4
Hemorrhage/Bleeding
3
3
Exposure to Body Fluids
3
3
Fever
3
3
Abdominal Distention
3
3
Abdominal Pain
3
3
Skin Discoloration
2
2
Itching Sensation
2
2
Rash
2
2
Burning Sensation
2
2
Purulent Discharge
2
2
Abrasion
2
2
Muscle Spasm(s)
2
2
Sepsis
2
2
Pressure Sores
2
2
Incontinence
1
1
Irritation
1
1
Chills
1
1
Shock, Surgical
1
1
Injury
1
1
Thrombosis/Thrombus
1
1
Perforation
1
1
Head Injury
1
1
Brain Injury
1
1
Skin Irritation
1
1
Erythema
1
1
Swelling
1
1
Nausea
1
1
Fall
1
1
Scar Tissue
1
1
Tachycardia
1
1
Ulceration
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
2
Teleflex Medical
III
Jul-15-2019
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