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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
Complete Blockage 37 37
Device Contamination with Chemical or Other Material 37 37
Dent in Material 35 35
Deformation Due to Compressive Stress 33 33
Material Twisted/Bent 33 33
Inadequate Instructions for Healthcare Professional 33 33
Short Fill 31 31
Device Handling Problem 31 31
Patient-Device Incompatibility 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
Misassembled 24 24
No Display/Image 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
Material Protrusion/Extrusion 16 16
Naturally Worn 16 16
Defective Device 16 16
Insufficient Information 15 15
Expiration Date Error 14 14
Device Damaged Prior to Use 14 14
Material Integrity Problem 14 14
Collapse 14 14
Inadequacy of Device Shape and/or Size 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
Filling Problem 8 8
Sharp Edges 8 8
Therapeutic or Diagnostic Output Failure 8 8
Inaccurate Information 7 7
No Apparent Adverse Event 7 7
Infusion or Flow Problem 7 7
Material Separation 7 7
Product Quality Problem 6 6
Crack 6 6
Noise, Audible 6 6
Positioning Problem 6 6
Output Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Failure to Advance 5 5
Malposition of Device 5 5
Entrapment of Device 5 5
Unsealed Device Packaging 5 5
Shipping Damage or Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Degraded 4 4
Flaked 4 4
Material Discolored 4 4
Labelling, Instructions for Use or Training Problem 4 4
Contamination /Decontamination Problem 4 4
Fungus in Device Environment 4 4
Improper Chemical Reaction 4 4
Improper Flow or Infusion 4 4
Packaging Problem 4 4
Scratched Material 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
Irritation 8 8
Unspecified Gastrointestinal Problem 8 8
Abdominal Pain 7 7
Distress 7 7
Reaction 7 7
Irritability 6 6
Tissue Damage 6 6
Swelling 6 6
Laceration(s) 5 5
Bacterial Infection 5 5
Erythema 5 5
Fever 5 5
Pressure Sores 5 5
Blood Loss 5 5
Skin Discoloration 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Swelling/ Edema 4 4
Localized Skin Lesion 3 3
Rash 3 3
Muscle Spasm(s) 3 3
Micturition Urgency 3 3
Injury 3 3
Anxiety 3 3
Burning Sensation 3 3
Chills 2 2
Depression 2 2
Inadequate Pain Relief 2 2
Skin Tears 2 2
High Blood Pressure/ Hypertension 2 2
Calcium Deposits/Calcification 2 2
Local Reaction 2 2
Sepsis 2 2
Thrombus 2 2
Unspecified Tissue Injury 2 2
Not Applicable 2 2
Convulsion/Seizure 2 2
Alteration In Body Temperature 2 2
Dysuria 1 1
Urethral Stenosis/Stricture 1 1
Genital Bleeding 1 1
Skin Irritation 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Itching Sensation 1 1
Cyst(s) 1 1
Death 1 1
Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Hematoma 1 1
Confusion/ Disorientation 1 1
Inadequate Osseointegration 1 1
Bowel Perforation 1 1
Obstruction/Occlusion 1 1
Spinal Cord Injury 1 1
Cramp(s) 1 1
Discharge 1 1
Excessive Tear Production 1 1
Subclinical Infection 1 1
Sneezing 1 1
Urinary Frequency 1 1
Tingling 1 1
Uterine Perforation 1 1
Abnormal Vaginal Discharge 1 1
Ulceration 1 1

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