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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


Premarket Reviews
ManufacturerDecision
FUTURE PATH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 21 21
2016 82 82
2017 154 154
2018 190 190
2019 235 235
2020 215 215
2021 209 209
2022 167 167
2023 178 178
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 502 502
No Flow 157 157
Deformation Due to Compressive Stress 132 132
Component Missing 83 83
Fluid/Blood Leak 68 68
Obstruction of Flow 60 60
Material Twisted/Bent 59 59
Device Operates Differently Than Expected 58 58
Component Misassembled 54 54
Leak/Splash 48 48
Device Contamination with Chemical or Other Material 47 47
Kinked 43 43
Adverse Event Without Identified Device or Use Problem 39 39
Partial Blockage 34 34
Deflation Problem 32 32
Improper Flow or Infusion 31 31
Physical Resistance/Sticking 30 30
Infusion or Flow Problem 27 27
Material Deformation 27 27
Disconnection 25 25
Detachment of Device or Device Component 19 19
Patient-Device Incompatibility 17 17
Biocompatibility 17 17
Inaccurate Flow Rate 15 15
Backflow 13 13
Difficult to Open or Close 13 13
Misassembled 12 12
Nonstandard Device 11 11
Material Fragmentation 11 11
Inadequate Instructions for Healthcare Professional 11 11
Break 10 10
Complete Blockage 10 10
Insufficient Flow or Under Infusion 10 10
Use of Device Problem 10 10
Expiration Date Error 10 10
Insufficient Information 10 10
Appropriate Term/Code Not Available 10 10
Sticking 9 9
Difficult to Remove 9 9
Hole In Material 8 8
Therapeutic or Diagnostic Output Failure 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Device Markings/Labelling Problem 8 8
Defective Device 7 7
Device Handling Problem 7 7
Labelling, Instructions for Use or Training Problem 7 7
Occlusion Within Device 7 7
Short Fill 6 6
Suction Problem 6 6
Incorrect Measurement 6 6
Patient Device Interaction Problem 6 6
Output Problem 6 6
Material Split, Cut or Torn 6 6
Unintended Deflation 6 6
Tear, Rip or Hole in Device Packaging 6 6
Packaging Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
No Device Output 5 5
Material Rupture 5 5
Material Puncture/Hole 4 4
Improper or Incorrect Procedure or Method 4 4
Material Too Rigid or Stiff 4 4
Mechanical Problem 4 4
Bent 4 4
Illegible Information 4 4
Fungus in Device Environment 4 4
Contamination /Decontamination Problem 4 4
Difficult to Open or Remove Packaging Material 4 4
Connection Problem 4 4
Device Packaging Compromised 4 4
Material Integrity Problem 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Material Protrusion/Extrusion 3 3
Gas/Air Leak 3 3
Missing Information 3 3
Failure to Deflate 3 3
Activation Problem 3 3
Material Too Soft/Flexible 3 3
Collapse 3 3
Contamination 3 3
Loose or Intermittent Connection 3 3
Delivered as Unsterile Product 3 3
Inflation Problem 3 3
Fracture 3 3
Device Inoperable 3 3
Defective Component 3 3
Material Separation 3 3
Shipping Damage or Problem 3 3
Product Quality Problem 2 2
Material Opacification 2 2
Out-Of-Box Failure 2 2
Inadequate or Insufficient Training 2 2
Moisture Damage 2 2
Crack 2 2
Filling Problem 2 2
Detachment Of Device Component 2 2
Calcified 2 2
Misassembly by Users 2 2
Sharp Edges 2 2
Improper Device Output 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 544 544
No Known Impact Or Consequence To Patient 490 490
No Consequences Or Impact To Patient 443 443
No Patient Involvement 92 92
Urinary Tract Infection 88 88
No Information 60 60
Pain 36 36
Unspecified Infection 33 33
Urinary Retention 31 31
Discomfort 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Insufficient Information 12 12
No Code Available 11 11
Patient Problem/Medical Problem 9 9
Hematuria 6 6
Hemorrhage/Bleeding 6 6
Fever 5 5
Skin Irritation 5 5
Muscle Spasm(s) 4 4
Pressure Sores 4 4
Foreign Body In Patient 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Skin Inflammation/ Irritation 4 4
Alteration In Body Temperature 3 3
Injury 3 3
Burn(s) 3 3
Abdominal Pain 3 3
Abrasion 3 3
Bacterial Infection 3 3
Exposure to Body Fluids 3 3
Swelling 3 3
Rash 3 3
Sepsis 3 3
Burning Sensation 3 3
Fall 2 2
Skin Discoloration 2 2
Irritation 2 2
Itching Sensation 2 2
Reaction 2 2
Abdominal Distention 2 2
Tissue Breakdown 1 1
Test Result 1 1
Chemical Exposure 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Hypersensitivity/Allergic reaction 1 1
Incontinence 1 1
Internal Organ Perforation 1 1
Perforation 1 1
Bruise/Contusion 1 1
Dyspnea 1 1
Erythema 1 1
Head Injury 1 1
Scar Tissue 1 1
Scarring 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Ulceration 1 1
Chills 1 1
Brain Injury 1 1
Shock, Surgical 1 1
Ulcer 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 C.R. Bard, Inc. III Aug-03-2016
4 C.R. Bard, Inc. II Apr-01-2015
5 Cardinal Health 200, LLC I Feb-16-2024
6 Covidien LP II May-27-2011
7 Customed, Inc II Sep-03-2015
8 Teleflex Medical III Jul-15-2019
9 Teleflex Medical II Apr-22-2013
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