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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, coude
Product CodeEZC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 14 14
2015 20 20
2016 170 170
2017 963 963
2018 886 886
2019 1000 1000
2020 1027 1027
2021 1030 1030
2022 1365 1365
2023 1156 1156
2024 677 677

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 1140 1140
Burst Container or Vessel 983 983
Fluid/Blood Leak 881 881
Difficult to Remove 743 743
Material Puncture/Hole 502 502
Decrease in Pressure 497 497
Failure to Infuse 457 457
Partial Blockage 377 377
Inflation Problem 354 354
Break 336 336
Leak/Splash 317 317
Material Rupture 317 317
Inaccurate Flow Rate 308 308
Device Dislodged or Dislocated 219 219
Material Fragmentation 219 219
Adverse Event Without Identified Device or Use Problem 199 199
Erratic or Intermittent Display 163 163
Device Fell 154 154
No Flow 142 142
Material Split, Cut or Torn 132 132
Component Missing 131 131
Component Falling 126 126
Device Operates Differently Than Expected 106 106
Patient Device Interaction Problem 97 97
Device Sensing Problem 92 92
Device Slipped 78 78
Biocompatibility 75 75
Obstruction of Flow 75 75
Component Misassembled 71 71
Material Deformation 67 67
Incorrect Measurement 66 66
Disconnection 66 66
Detachment of Device or Device Component 65 65
Material Invagination 59 59
Illegible Information 56 56
Device Contamination with Chemical or Other Material 55 55
Inadequate or Insufficient Training 55 55
Patient-Device Incompatibility 55 55
Difficult to Insert 54 54
Complete Blockage 53 53
Hole In Material 52 52
Calcified 50 50
Detachment Of Device Component 50 50
Tear, Rip or Hole in Device Packaging 43 43
Material Twisted/Bent 42 42
Dent in Material 40 40
Deformation Due to Compressive Stress 40 40
Device Handling Problem 39 39
Use of Device Problem 38 38
Inadequate Instructions for Healthcare Professional 38 38

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3699 3699
No Known Impact Or Consequence To Patient 2455 2455
No Consequences Or Impact To Patient 2002 2002
No Patient Involvement 472 472
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 380 380
Pain 275 275
Urinary Tract Infection 199 199
No Information 186 186
Foreign Body In Patient 165 165
Patient Problem/Medical Problem 148 148
No Code Available 134 134
Discomfort 119 119
Hematuria 103 103
Urinary Retention 93 93
Hemorrhage/Bleeding 59 59
Unspecified Infection 49 49
Insufficient Information 48 48
Hypersensitivity/Allergic reaction 27 27
Tissue Breakdown 24 24
Device Embedded In Tissue or Plaque 22 22
Fistula 21 21
Reaction 19 19
Incontinence 18 18
Injury 16 16
Erosion 16 16
Cancer 14 14
Blood Loss 14 14
Abdominal Distention 14 14
Perforation 14 14
Skin Inflammation/ Irritation 13 13
Abdominal Pain 13 13
Irritation 12 12
Tissue Damage 10 10
Alteration In Body Temperature 10 10
Exposure to Body Fluids 10 10
Inflammation 9 9
Swelling 9 9
Bacterial Infection 8 8
Abrasion 8 8
Unspecified Gastrointestinal Problem 8 8
Burning Sensation 8 8
Muscle Spasm(s) 8 8
Pressure Sores 7 7
Fever 7 7
Death 7 7
Distress 7 7
Erythema 7 7
Swelling/ Edema 6 6
Laceration(s) 6 6
Irritability 6 6

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 C.R. Bard, Inc. II Jun-06-2018
3 C.R. Bard, Inc., Urological Division II Sep-07-2012
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