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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
2016 82 82
2017 154 154
2018 190 190
2019 235 235
2020 213 213
2021 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 311 311
No Flow 152 152
Deformation Due to Compressive Stress 69 69
Component Missing 64 64
Device Operates Differently Than Expected 57 57
Material Twisted/Bent 44 44
Obstruction of Flow 42 42
Kinked 41 41
Leak/Splash 38 38
Device Contamination with Chemical or Other Material 34 34
Fluid Leak 32 32
Deflation Problem 27 27
Material Deformation 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Improper Flow or Infusion 25 25
Infusion or Flow Problem 25 25
Patient-Device Incompatibility 17 17
Disconnection 17 17
Biocompatibility 15 15
Partial Blockage 14 14
Detachment of Device or Device Component 14 14
Backflow 13 13
Misassembled 12 12
Insufficient Flow or Under Infusion 10 10
Physical Resistance/Sticking 10 10
Complete Blockage 10 10
Inadequate Instructions for Healthcare Professional 9 9
Sticking 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Device Markings/Labelling Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Appropriate Term/Code Not Available 8 8
Expiration Date Error 7 7
Break 7 7
Difficult to Remove 7 7
Inaccurate Flow Rate 7 7
Suction Problem 6 6
Labelling, Instructions for Use or Training Problem 6 6
Output Problem 6 6
Packaging Problem 5 5
Defective Device 5 5
Use of Device Problem 5 5
Difficult to Open or Close 5 5
No Device Output 5 5
Short Fill 5 5
Component Misassembled 5 5
Material Integrity Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Contamination /Decontamination Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Occlusion Within Device 4 4
Bent 4 4
Mechanical Problem 4 4
Material Fragmentation 4 4
Hole In Material 4 4
Insufficient Information 4 4
Gas Leak 3 3
Inadequate Instructions for Non-Healthcare Professional 3 3
Material Split, Cut or Torn 3 3
Loose or Intermittent Connection 3 3
Contamination 3 3
Connection Problem 3 3
Defective Component 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Inoperable 3 3
Product Quality Problem 2 2
Fungus in Device Environment 2 2
Detachment Of Device Component 2 2
Delivered as Unsterile Product 2 2
Device Contaminated During Manufacture or Shipping 2 2
Improper Device Output 2 2
Material Protrusion/Extrusion 2 2
Device Handling Problem 2 2
Mechanical Jam 2 2
Device Operational Issue 2 2
Folded 2 2
Inflation Problem 2 2
Incorrect Measurement 2 2
Filling Problem 2 2
Material Opacification 2 2
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Out-Of-Box Failure 2 2
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Microbial Contamination of Device 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Problem with Sterilization 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Collapse 1 1
Crack 1 1
Loss of or Failure to Bond 1 1
Inability to Auto-Fill 1 1
Melted 1 1
Device Emits Odor 1 1
Split 1 1
Blocked Connection 1 1
Computer Operating System Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 481 481
No Consequences Or Impact To Patient 431 431
No Patient Involvement 91 91
Urinary Tract Infection 63 63
No Information 58 58
No Clinical Signs, Symptoms or Conditions 51 51
Urinary Retention 22 22
Unspecified Infection 20 20
Pain 19 19
Discomfort 14 14
No Code Available 11 11
Patient Problem/Medical Problem 9 9
Hemorrhage/Bleeding 5 5
Skin Irritation 5 5
Muscle Spasm(s) 4 4
Fever 4 4
Hematuria 3 3
Swelling 3 3
Injury 3 3
Foreign Body In Patient 3 3
Reaction 2 2
Burning Sensation 2 2
Abdominal Pain 2 2
Abrasion 2 2
Irritation 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Burn(s) 1 1
Erythema 1 1
Fall 1 1
Perforation 1 1
Rash 1 1
Sepsis 1 1
Skin Discoloration 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Ulceration 1 1
Shock, Surgical 1 1
Ulcer 1 1
Pressure Sores 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Incontinence 1 1
Scarring 1 1
Complaint, Ill-Defined 1 1
Chemical Exposure 1 1
Tissue Breakdown 1 1
Test Result 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 Teleflex Medical III Jul-15-2019
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