• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 122 122

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 417 417
Deformation Due to Compressive Stress 142 142
Component Missing 69 69
Component Misassembled 57 57
Material Twisted/Bent 56 56
Fluid/Blood Leak 49 49
Obstruction of Flow 49 49
No Flow 47 47
Partial Blockage 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Physical Resistance/Sticking 27 27
Device Contamination with Chemical or Other Material 26 26
Deflation Problem 25 25
Leak/Splash 23 23
Disconnection 21 21
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
Material Fragmentation 14 14
Difficult to Open or Close 12 12
Backflow 12 12
Nonstandard Device 11 11
Expiration Date Error 9 9
Use of Device Problem 9 9
Complete Blockage 8 8
Therapeutic or Diagnostic Output Failure 8 8
Device Markings/Labelling Problem 7 7
Device Handling Problem 7 7
Break 7 7
Difficult to Remove 7 7
Incorrect Measurement 6 6
Patient-Device Incompatibility 6 6
Misassembled 6 6
Unintended Deflation 6 6
Material Split, Cut or Torn 6 6
Inadequate Instructions for Healthcare Professional 6 6
Suction Problem 6 6
Patient Device Interaction Problem 6 6
Appropriate Term/Code Not Available 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Defective Device 5 5
Short Fill 5 5
Material Too Rigid or Stiff 4 4
Difficult to Open or Remove Packaging Material 4 4
Illegible Information 4 4
Material Puncture/Hole 4 4
Fracture 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 598 598
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 54 54
Pain 29 29
Unspecified Infection 22 22
Urinary Retention 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Discomfort 16 16
Insufficient Information 12 12
Patient Problem/Medical Problem 6 6
No Code Available 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Hematuria 4 4
No Information 4 4
Skin Inflammation/ Irritation 4 4
Micturition Urgency 4 4
Foreign Body In Patient 4 4
Hemorrhage/Bleeding 3 3
Exposure to Body Fluids 3 3
Fever 3 3
Abdominal Distention 3 3
Abdominal Pain 3 3
Skin Discoloration 2 2
Itching Sensation 2 2
Rash 2 2
Burning Sensation 2 2
Purulent Discharge 2 2
Abrasion 2 2
Muscle Spasm(s) 2 2
Sepsis 2 2
Pressure Sores 2 2
Incontinence 1 1
Irritation 1 1
Chills 1 1
Shock, Surgical 1 1
Injury 1 1
Thrombosis/Thrombus 1 1
Perforation 1 1
Head Injury 1 1
Brain Injury 1 1
Skin Irritation 1 1
Erythema 1 1
Swelling 1 1
Nausea 1 1
Fall 1 1
Scar Tissue 1 1
Tachycardia 1 1
Ulceration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 Teleflex Medical III Jul-15-2019
-
-