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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
2017 154 154
2018 190 190
2019 235 235
2020 215 215
2021 219 219

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 363 363
No Flow 131 131
Deformation Due to Compressive Stress 85 85
Component Missing 70 70
Material Twisted/Bent 48 48
Obstruction of Flow 46 46
Device Contamination with Chemical or Other Material 44 44
Device Operates Differently Than Expected 42 42
Fluid Leak 38 38
Kinked 33 33
Leak/Splash 31 31
Deflation Problem 30 30
Material Deformation 27 27
Infusion or Flow Problem 25 25
Adverse Event Without Identified Device or Use Problem 24 24
Improper Flow or Infusion 20 20
Detachment of Device or Device Component 19 19
Component Misassembled 19 19
Partial Blockage 19 19
Disconnection 18 18
Biocompatibility 18 18
Patient-Device Incompatibility 16 16
Backflow 13 13
Misassembled 12 12
Inadequate Instructions for Healthcare Professional 11 11
Physical Resistance/Sticking 11 11
Inaccurate Flow Rate 10 10
Complete Blockage 10 10
Insufficient Flow or Under Infusion 9 9
Break 8 8
Appropriate Term/Code Not Available 8 8
Therapeutic or Diagnostic Output Failure 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Expiration Date Error 8 8
Device Markings/Labelling Problem 8 8
Defective Device 7 7
Output Problem 7 7
Difficult to Remove 7 7
Sticking 6 6
Use of Device Problem 6 6
Suction Problem 6 6
Labelling, Instructions for Use or Training Problem 6 6
Short Fill 5 5
Packaging Problem 5 5
Contamination /Decontamination Problem 4 4
Difficult to Open or Close 4 4
Material Integrity Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Improper or Incorrect Procedure or Method 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Rupture 4 4
Mechanical Problem 4 4
Occlusion Within Device 4 4
No Device Output 4 4
Material Fragmentation 4 4
Hole In Material 4 4
Loose or Intermittent Connection 3 3
Contamination 3 3
Material Separation 3 3
Shipping Damage or Problem 3 3
Fungus in Device Environment 3 3
Defective Component 3 3
Device Inoperable 3 3
Inadequate Instructions for Non-Healthcare Professional 3 3
Gas Leak 3 3
Connection Problem 3 3
Material Split, Cut or Torn 3 3
Material Too Soft/Flexible 2 2
Insufficient Information 2 2
Device Handling Problem 2 2
Illegible Information 2 2
Missing Information 2 2
Device Operational Issue 2 2
Improper Device Output 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Out-Of-Box Failure 2 2
Material Opacification 2 2
Material Too Rigid or Stiff 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Detachment Of Device Component 2 2
Bent 2 2
Incorrect Measurement 2 2
Moisture Damage 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
Inflation Problem 2 2
Fracture 1 1
Inability to Auto-Fill 1 1
Loss of or Failure to Bond 1 1
Calcified 1 1
Failure to Capture 1 1
Collapse 1 1
Crack 1 1
Filling Problem 1 1
Material Discolored 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 448 448
No Consequences Or Impact To Patient 422 422
No Clinical Signs, Symptoms or Conditions 216 216
No Patient Involvement 89 89
Urinary Tract Infection 63 63
No Information 50 50
Pain 22 22
Unspecified Infection 18 18
Urinary Retention 15 15
Discomfort 13 13
Patient Problem/Medical Problem 9 9
Insufficient Information 9 9
No Code Available 8 8
Hemorrhage/Bleeding 5 5
Fever 4 4
Muscle Spasm(s) 4 4
Hematuria 4 4
Skin Irritation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 3 3
Injury 3 3
Swelling 2 2
Burning Sensation 2 2
Sepsis 2 2
Irritation 2 2
Abdominal Pain 2 2
Abrasion 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Test Result 1 1
Tissue Breakdown 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Erythema 1 1
Fall 1 1
Incontinence 1 1
Perforation 1 1
Rash 1 1
Skin Discoloration 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Ulceration 1 1
Chemical Exposure 1 1
Brain Injury 1 1
Shock, Surgical 1 1
Ulcer 1 1
Pressure Sores 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Aug-10-2017
2 C.R. Bard, Inc. II Jan-09-2017
3 Teleflex Medical III Jul-15-2019
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