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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 1

MDR Year MDR Reports MDR Events
2019 1000 1000
2020 1027 1027
2021 1030 1030
2022 1365 1365
2023 1155 1155
2024 200 200

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 796 796
Deflation Problem 643 643
Fluid/Blood Leak 640 640
Difficult to Remove 563 563
Decrease in Pressure 486 486
Material Puncture/Hole 395 395
Failure to Infuse 374 374
Partial Blockage 270 270
Inaccurate Flow Rate 237 237
Material Fragmentation 191 191
Adverse Event Without Identified Device or Use Problem 180 180
Material Rupture 162 162
Leak/Splash 155 155
Erratic or Intermittent Display 153 153
Inflation Problem 152 152
Break 135 135
Material Split, Cut or Torn 125 125
Device Fell 124 124
Patient Device Interaction Problem 93 93
Device Dislodged or Dislocated 78 78
Device Sensing Problem 75 75
Biocompatibility 74 74
Device Slipped 70 70
Component Missing 67 67
Component Misassembled 65 65
Illegible Information 56 56
Inadequate or Insufficient Training 55 55
Obstruction of Flow 54 54
Disconnection 52 52
Material Invagination 50 50
Incorrect Measurement 47 47
Calcified 46 46
Material Deformation 44 44
No Flow 40 40
Detachment of Device or Device Component 39 39
Difficult to Insert 38 38
Device Contamination with Chemical or Other Material 37 37
Complete Blockage 37 37
Dent in Material 35 35
Inadequate Instructions for Healthcare Professional 33 33
Deformation Due to Compressive Stress 33 33
Material Twisted/Bent 33 33
Patient-Device Incompatibility 31 31
Device Handling Problem 31 31
Short Fill 31 31
Tear, Rip or Hole in Device Packaging 30 30
Missing Information 29 29
Nonstandard Device 27 27
Fracture 26 26
Use of Device Problem 25 25
No Display/Image 24 24
Misassembled 24 24
Physical Resistance/Sticking 24 24
Gel Leak 23 23
Defective Component 19 19
Inability to Irrigate 17 17
Restricted Flow rate 17 17
Defective Device 16 16
Naturally Worn 16 16
Material Protrusion/Extrusion 16 16
Insufficient Information 15 15
Collapse 14 14
Device Damaged Prior to Use 14 14
Inadequacy of Device Shape and/or Size 14 14
Material Integrity Problem 14 14
Expiration Date Error 14 14
Gas/Air Leak 11 11
Unclear Information 11 11
Device Markings/Labelling Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Fitting Problem 9 9
Sharp Edges 8 8
Filling Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
No Apparent Adverse Event 7 7
Infusion or Flow Problem 7 7
Material Separation 7 7
Inaccurate Information 7 7
Noise, Audible 6 6
Crack 6 6
Positioning Problem 6 6
Product Quality Problem 6 6
Failure to Advance 5 5
Shipping Damage or Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Entrapment of Device 5 5
Malposition of Device 5 5
Output Problem 5 5
Unsealed Device Packaging 5 5
Improper Flow or Infusion 4 4
Failure to Deflate 4 4
Labelling, Instructions for Use or Training Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Packaging Problem 4 4
Improper Chemical Reaction 4 4
Flaked 4 4
Fungus in Device Environment 4 4
Scratched Material 4 4
Appropriate Term/Code Not Available 4 4
Degraded 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3285 3285
No Consequences Or Impact To Patient 1431 1431
No Known Impact Or Consequence To Patient 1174 1174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 355 355
No Patient Involvement 301 301
Pain 214 214
Urinary Tract Infection 153 153
Foreign Body In Patient 130 130
Patient Problem/Medical Problem 118 118
Hematuria 83 83
Discomfort 78 78
No Code Available 66 66
Insufficient Information 47 47
Unspecified Infection 36 36
Urinary Retention 34 34
Hemorrhage/Bleeding 24 24
Tissue Breakdown 22 22
Fistula 21 21
No Information 20 20
Hypersensitivity/Allergic reaction 19 19
Erosion 15 15
Perforation 14 14
Cancer 14 14
Device Embedded In Tissue or Plaque 13 13
Skin Inflammation/ Irritation 12 12
Incontinence 12 12
Abdominal Distention 11 11
Exposure to Body Fluids 9 9
Abrasion 8 8
Inflammation 8 8
Unspecified Gastrointestinal Problem 8 8
Irritation 8 8
Distress 7 7
Abdominal Pain 7 7
Reaction 7 7
Irritability 6 6
Tissue Damage 6 6
Swelling 6 6
Laceration(s) 5 5
Blood Loss 5 5
Erythema 5 5
Fever 5 5
Pressure Sores 5 5
Bacterial Infection 5 5
Swelling/ Edema 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Skin Discoloration 4 4
Anxiety 3 3
Burning Sensation 3 3
Muscle Spasm(s) 3 3
Localized Skin Lesion 3 3
Micturition Urgency 3 3
Rash 3 3
Injury 3 3
Depression 2 2
High Blood Pressure/ Hypertension 2 2
Thrombus 2 2
Calcium Deposits/Calcification 2 2
Inadequate Pain Relief 2 2
Local Reaction 2 2
Skin Tears 2 2
Not Applicable 2 2
Unspecified Tissue Injury 2 2
Chills 2 2
Convulsion/Seizure 2 2
Alteration In Body Temperature 2 2
Sepsis 2 2
Excessive Tear Production 1 1
Genital Bleeding 1 1
Inadequate Osseointegration 1 1
Bowel Perforation 1 1
Cramp(s) 1 1
Discharge 1 1
Spinal Cord Injury 1 1
Abnormal Vaginal Discharge 1 1
Cyst(s) 1 1
Confusion/ Disorientation 1 1
Death 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Uterine Perforation 1 1
Urinary Frequency 1 1
Low Blood Pressure/ Hypotension 1 1
Dysuria 1 1
Hematoma 1 1
Ulceration 1 1
Edema 1 1
Obstruction/Occlusion 1 1
Tingling 1 1
Sneezing 1 1
Skin Irritation 1 1
Itching Sensation 1 1
Urethral Stenosis/Stricture 1 1
Subclinical Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
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