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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
Product CodeKNX
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 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 376 376
Deformation Due to Compressive Stress 124 124
Component Missing 69 69
Material Twisted/Bent 52 52
Component Misassembled 52 52
Obstruction of Flow 49 49
No Flow 47 47
Fluid/Blood Leak 43 43
Partial Blockage 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Device Contamination with Chemical or Other Material 26 26
Deflation Problem 25 25
Physical Resistance/Sticking 24 24
Disconnection 21 21
Leak/Splash 20 20
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
Backflow 12 12
Nonstandard Device 11 11
Difficult to Open or Close 11 11
Expiration Date Error 9 9
Use of Device Problem 9 9
Material Fragmentation 9 9
Complete Blockage 8 8
Therapeutic or Diagnostic Output Failure 8 8
Device Handling Problem 7 7
Break 7 7
Difficult to Remove 7 7
Device Markings/Labelling Problem 7 7
Patient-Device Incompatibility 6 6
Suction Problem 6 6
Inadequate Instructions for Healthcare Professional 6 6
Incorrect Measurement 6 6
Misassembled 6 6
Patient Device Interaction Problem 6 6
Material Split, Cut or Torn 6 6
Unintended Deflation 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Defective Device 5 5
Difficult to Open or Remove Packaging Material 4 4
Short Fill 4 4
Material Puncture/Hole 4 4
Material Too Rigid or Stiff 4 4
Appropriate Term/Code Not Available 4 4
Illegible Information 4 4
Activation Problem 3 3
Missing Information 3 3
Failure to Deflate 3 3
Material Too Soft/Flexible 3 3
Insufficient Information 3 3
Material Protrusion/Extrusion 3 3
Material Rupture 3 3
Inflation Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Fracture 3 3
Collapse 3 3
Inadequacy of Device Shape and/or Size 3 3
Defective Component 3 3
Fungus in Device Environment 3 3
Contamination /Decontamination Problem 3 3
Inadequate or Insufficient Training 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Insufficient Flow or Under Infusion 2 2
Contamination 2 2
Calcified 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Output Problem 2 2
Packaging Problem 2 2
Sharp Edges 2 2
Migration 1 1
Noise, Audible 1 1
Wrong Label 1 1
Inaccurate Information 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Particulates 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Moisture Damage 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Filling Problem 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Incomplete or Missing Packaging 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 522 522
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 52 52
Pain 22 22
Unspecified Infection 21 21
Urinary Retention 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Discomfort 14 14
Insufficient Information 12 12
Patient Problem/Medical Problem 6 6
No Code Available 5 5
No Information 4 4
Hematuria 4 4
Foreign Body In Patient 4 4
Skin Inflammation/ Irritation 3 3
Abdominal Pain 3 3
Hemorrhage/Bleeding 3 3
Fever 2 2
Abrasion 2 2
Exposure to Body Fluids 2 2
Itching Sensation 2 2
Muscle Spasm(s) 2 2
Rash 2 2
Burning Sensation 2 2
Pressure Sores 2 2
Sepsis 2 2
Abdominal Distention 2 2
Injury 1 1
Tissue Breakdown 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Ulceration 1 1
Distress 1 1
Chills 1 1
Brain Injury 1 1
Shock, Surgical 1 1
Ulcer 1 1
Scar Tissue 1 1
Perforation 1 1
Internal Organ Perforation 1 1
Irritation 1 1
Erythema 1 1
Fall 1 1
Bacterial Infection 1 1
Head Injury 1 1
Incontinence 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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