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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
2018 190 190
2019 235 235
2020 215 215
2021 223 223
2022 177 177
2023 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 423 423
Deformation Due to Compressive Stress 115 115
No Flow 102 102
Component Missing 72 72
Material Twisted/Bent 57 57
Obstruction of Flow 51 51
Component Misassembled 44 44
Fluid/Blood Leak 42 42
Device Contamination with Chemical or Other Material 33 33
Deflation Problem 31 31
Partial Blockage 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Material Deformation 26 26
Leak/Splash 24 24
Infusion or Flow Problem 23 23
Physical Resistance/Sticking 21 21
Device Operates Differently Than Expected 20 20
Detachment of Device or Device Component 19 19
Improper Flow or Infusion 19 19
Disconnection 19 19
Biocompatibility 18 18
Patient-Device Incompatibility 16 16
Inaccurate Flow Rate 13 13
Backflow 13 13
Inadequate Instructions for Healthcare Professional 10 10
Use of Device Problem 10 10
Expiration Date Error 9 9
Difficult to Remove 9 9
Material Fragmentation 9 9
Break 9 9
Difficult to Open or Close 9 9
Therapeutic or Diagnostic Output Failure 8 8
Complete Blockage 8 8
Kinked 8 8
Misassembled 8 8
Defective Device 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Device Markings/Labelling Problem 7 7
Output Problem 6 6
Appropriate Term/Code Not Available 6 6
Suction Problem 6 6
Labelling, Instructions for Use or Training Problem 6 6
Nonstandard Device 6 6
Incorrect Measurement 6 6
Short Fill 5 5
Device Handling Problem 5 5
Packaging Problem 5 5
Contamination /Decontamination Problem 4 4
Difficult to Open or Remove Packaging Material 4 4
Illegible Information 4 4
Material Split, Cut or Torn 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Puncture/Hole 4 4
Material Too Rigid or Stiff 4 4
Material Rupture 4 4
Insufficient Flow or Under Infusion 4 4
Fungus in Device Environment 4 4
Tear, Rip or Hole in Device Packaging 4 4
Mechanical Problem 4 4
Occlusion Within Device 3 3
Loose or Intermittent Connection 3 3
Inflation Problem 3 3
Contamination 3 3
Defective Component 3 3
Material Separation 3 3
Shipping Damage or Problem 3 3
Material Too Soft/Flexible 3 3
Missing Information 3 3
Failure to Deflate 3 3
Activation Problem 3 3
Gas/Air Leak 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Patient Device Interaction Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Connection Problem 2 2
Device Operational Issue 2 2
Insufficient Information 2 2
Product Quality Problem 2 2
Delivered as Unsterile Product 2 2
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Collapse 2 2
Moisture Damage 2 2
Melted 1 1
Material Opacification 1 1
No Device Output 1 1
Particulates 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Fracture 1 1
Calcified 1 1
Failure to Capture 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Material Discolored 1 1
Filling Problem 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 426 426
No Consequences Or Impact To Patient 407 407
No Known Impact Or Consequence To Patient 366 366
No Patient Involvement 85 85
Urinary Tract Infection 61 61
Pain 23 23
Unspecified Infection 22 22
No Information 19 19
Discomfort 15 15
Urinary Retention 14 14
Insufficient Information 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Patient Problem/Medical Problem 9 9
No Code Available 7 7
Hemorrhage/Bleeding 6 6
Fever 5 5
Hematuria 4 4
Foreign Body In Patient 4 4
Skin Inflammation/ Irritation 3 3
Abrasion 3 3
Muscle Spasm(s) 3 3
Injury 3 3
Pressure Sores 3 3
Skin Irritation 3 3
Swelling 2 2
Sepsis 2 2
Abdominal Pain 2 2
Irritation 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Tissue Breakdown 1 1
Perforation 1 1
Rash 1 1
Scar Tissue 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Fall 1 1
Head Injury 1 1
Incontinence 1 1
Skin Discoloration 1 1
Burning Sensation 1 1
Chills 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Ulceration 1 1
Distress 1 1
Brain Injury 1 1
Shock, Surgical 1 1
Ulcer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical III Jul-15-2019
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