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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, coude
Regulation Description Urological catheter and accessories.
Product CodeEZC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 20 20
2016 170 170
2017 963 963
2018 886 886
2019 1000 1000
2020 1032 1032
2021 407 407

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 1071 1071
Burst Container or Vessel 522 522
Fluid Leak 482 482
Difficult to Remove 416 416
Break 334 334
Inflation Problem 332 332
Leak/Splash 315 315
Failure to Infuse 233 233
Device Dislodged or Dislocated 214 214
Material Rupture 204 204
Partial Blockage 204 204
Decrease in Pressure 181 181
Device Fell 154 154
Inaccurate Flow Rate 147 147
No Flow 142 142
Component Falling 126 126
Device Operates Differently Than Expected 103 103
Component Missing 101 101
Device Slipped 77 77
Material Puncture/Hole 76 76
Obstruction of Flow 75 75
Material Split, Cut or Torn 72 72
Detachment of Device or Device Component 64 64
Material Deformation 64 64
Adverse Event Without Identified Device or Use Problem 56 56
Patient-Device Incompatibility 55 55
Hole In Material 51 51
Detachment Of Device Component 50 50
Biocompatibility 47 47
Complete Blockage 47 47
Material Fragmentation 44 44
Incorrect Measurement 39 39
Misassembled 38 38
Difficult to Insert 37 37
Device Damaged Prior to Use 34 34
Use of Device Problem 32 32
Disconnection 28 28
Restricted Flow rate 28 28
Defective Component 26 26
Material Integrity Problem 26 26
Device Contamination with Chemical or Other Material 26 26
Deformation Due to Compressive Stress 26 26
Material Twisted/Bent 26 26
Improper or Incorrect Procedure or Method 24 24
Physical Resistance/Sticking 23 23
Material Invagination 22 22
Component Misassembled 21 21
Defective Device 20 20
Insufficient Information 20 20
Infusion or Flow Problem 19 19
Gel Leak 19 19
Inadequacy of Device Shape and/or Size 19 19
Short Fill 18 18
Filling Problem 18 18
Crack 18 18
Tear, Rip or Hole in Device Packaging 17 17
Device Markings/Labelling Problem 16 16
Inability to Irrigate 16 16
Device Sensing Problem 14 14
Inadequate Instructions for Healthcare Professional 14 14
Noise, Audible 13 13
Erratic or Intermittent Display 13 13
Insufficient Flow or Under Infusion 12 12
Appropriate Term/Code Not Available 12 12
Physical Resistance 12 12
Torn Material 11 11
Gas Leak 11 11
Positioning Problem 10 10
Malposition of Device 9 9
Product Quality Problem 9 9
Improper Flow or Infusion 9 9
Device Handling Problem 9 9
Naturally Worn 9 9
Labelling, Instructions for Use or Training Problem 9 9
Collapse 9 9
Calcified 9 9
Blocked Connection 8 8
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Packaging Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Material Discolored 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Aspiration Issue 7 7
Failure to Advance 7 7
Dent in Material 7 7
Occlusion Within Device 7 7
Sticking 7 7
Kinked 7 7
Missing Information 7 7
Material Separation 7 7
Degraded 7 7
Nonstandard Device 7 7
No Device Output 6 6
Physical Property Issue 6 6
Temperature Problem 6 6
Output Problem 6 6
Entrapment of Device 6 6
Mushroomed 6 6
Scratched Material 5 5
Material Protrusion/Extrusion 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2450 2450
No Consequences Or Impact To Patient 2014 2014
No Patient Involvement 472 472
No Clinical Signs, Symptoms or Conditions 375 375
No Information 186 186
Pain 149 149
Patient Problem/Medical Problem 148 148
No Code Available 134 134
Urinary Tract Infection 98 98
Urinary Retention 78 78
Discomfort 74 74
Foreign Body In Patient 73 73
Hemorrhage/Bleeding 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Hematuria 30 30
Insufficient Information 27 27
Unspecified Infection 27 27
Device Embedded In Tissue or Plaque 22 22
Reaction 16 16
Injury 14 14
Blood Loss 14 14
Irritation 12 12
Hypersensitivity/Allergic reaction 11 11
Tissue Damage 10 10
Swelling 9 9
Muscle Spasm(s) 8 8
Alteration In Body Temperature 8 8
Abdominal Pain 7 7
Death 7 7
Abdominal Distention 7 7
Erythema 6 6
Fever 6 6
Burning Sensation 6 6
Confusion/ Disorientation 6 6
Complaint, Ill-Defined 5 5
Bacterial Infection 5 5
Incontinence 5 5
Abrasion 4 4
Rash 4 4
Pressure Sores 4 4
Sedation 4 4
Thrombus 3 3
Anxiety 3 3
Distress 3 3
Laceration(s) 3 3
Inadequate Pain Relief 3 3
Not Applicable 2 2
Swelling/ Edema 2 2
Micturition Urgency 2 2
Purulent Discharge 2 2
Discharge 2 2
Hematoma 2 2
Erosion 2 2
Skin Irritation 2 2
Thrombosis 1 1
Calcium Deposits/Calcification 1 1
Dementia 1 1
Emotional Changes 1 1
Abscess 1 1
Aneurysm 1 1
Staphylococcus Aureus 1 1
Sepsis 1 1
Skin Discoloration 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Excessive Tear Production 1 1
Sneezing 1 1
Ulceration 1 1
Abnormal Vaginal Discharge 1 1
Cramp(s) 1 1
Collapse 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Sweating 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Edema 1 1
Fistula 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Chest Pain 1 1
Itching Sensation 1 1
Anaphylactic Shock 1 1
Hypoglycemia 1 1
Internal Organ Perforation 1 1
Pulmonary Infarction 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Tingling 1 1
Subclinical Infection 1 1
Uterine Perforation 1 1
Skin Inflammation/ Irritation 1 1
Test Result 1 1
Inadequate Osseointegration 1 1
Tissue Breakdown 1 1
Vascular System (Circulation), Impaired 1 1
Depression 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Jun-06-2018
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