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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collector, urine, (and accessories) for indwelling catheter
Regulation Description Urine collector and accessories.
Product CodeKNX
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2020 215 215
2021 209 209
2022 167 167
2023 178 178
2024 167 167
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 346 346
Deformation Due to Compressive Stress 141 141
Component Misassembled 63 63
Fluid/Blood Leak 54 54
Component Missing 48 48
Material Twisted/Bent 42 42
Obstruction of Flow 33 33
Partial Blockage 27 27
Physical Resistance/Sticking 25 25
Adverse Event Without Identified Device or Use Problem 22 22
No Flow 18 18
Deflation Problem 18 18
Disconnection 17 17
Biocompatibility 17 17
Leak/Splash 15 15
Detachment of Device or Device Component 15 15
Device Contamination with Chemical or Other Material 15 15
Material Fragmentation 14 14
Inaccurate Flow Rate 12 12
Material Deformation 12 12
Nonstandard Device 11 11
Difficult to Open or Close 11 11
Improper Flow or Infusion 8 8
Use of Device Problem 7 7
Infusion or Flow Problem 7 7
Material Split, Cut or Torn 7 7
Device Handling Problem 7 7
Material Too Soft/Flexible 6 6
Unintended Deflation 6 6
Patient Device Interaction Problem 6 6
Incorrect Measurement 6 6
Appropriate Term/Code Not Available 5 5
Fracture 5 5
Therapeutic or Diagnostic Output Failure 5 5
Break 5 5
Difficult to Remove 4 4
Illegible Information 4 4
Material Puncture/Hole 4 4
Difficult to Open or Remove Packaging Material 4 4
Material Rupture 4 4
Fungus in Device Environment 3 3
Expiration Date Error 3 3
Defective Device 3 3
Failure to Deflate 3 3
Inadequate Instructions for Healthcare Professional 3 3
Missing Information 3 3
Short Fill 3 3
Material Too Rigid or Stiff 3 3
Complete Blockage 3 3
Activation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 679 679
No Consequences Or Impact To Patient 155 155
No Known Impact Or Consequence To Patient 93 93
Urinary Tract Infection 42 42
No Patient Involvement 36 36
Pain 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Infection 17 17
Urinary Retention 17 17
Discomfort 16 16
Insufficient Information 12 12
Exposure to Body Fluids 7 7
Cramp(s) /Muscle Spasm(s) 5 5
Patient Problem/Medical Problem 4 4
No Code Available 4 4
Hematuria 4 4
Skin Inflammation/ Irritation 4 4
Micturition Urgency 4 4
Abdominal Distention 3 3
Foreign Body In Patient 3 3
Hemorrhage/Bleeding 3 3
Abdominal Pain 2 2
Sepsis 2 2
Abrasion 2 2
Purulent Discharge 2 2
Itching Sensation 2 2
Fever 2 2
Rash 2 2
Pressure Sores 2 2
Muscle Spasm(s) 2 2
Kidney Infection 1 1
Distress 1 1
Thrombus 1 1
Internal Organ Perforation 1 1
Therapeutic Effects, Unexpected 1 1
Bacterial Infection 1 1
Anxiety 1 1
Tachycardia 1 1
Scar Tissue 1 1
Fall 1 1
Swelling 1 1
Thrombosis/Thrombus 1 1
Injury 1 1
Shock, Surgical 1 1
Chills 1 1
Burning Sensation 1 1
Irritation 1 1
Skin Discoloration 1 1
Perforation 1 1
Head Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
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