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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 1156 1156
2024 302 302

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 813 813
Fluid/Blood Leak 650 650
Deflation Problem 644 644
Difficult to Remove 585 585
Decrease in Pressure 494 494
Material Puncture/Hole 409 409
Failure to Infuse 378 378
Partial Blockage 274 274
Inaccurate Flow Rate 243 243
Material Fragmentation 194 194
Adverse Event Without Identified Device or Use Problem 180 180
Material Rupture 163 163
Erratic or Intermittent Display 157 157
Leak/Splash 155 155
Inflation Problem 152 152
Break 135 135
Material Split, Cut or Torn 127 127
Device Fell 124 124
Patient Device Interaction Problem 93 93
Device Dislodged or Dislocated 78 78
Device Sensing Problem 76 76
Biocompatibility 74 74
Device Slipped 70 70
Component Missing 67 67
Component Misassembled 66 66
Illegible Information 56 56
Inadequate or Insufficient Training 55 55
Obstruction of Flow 54 54
Disconnection 53 53
Material Invagination 51 51
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 39 39
Device Contamination with Chemical or Other Material 38 38
Complete Blockage 37 37
Dent in Material 35 35
Material Twisted/Bent 34 34
Deformation Due to Compressive Stress 33 33
Inadequate Instructions for Healthcare Professional 33 33
Device Handling Problem 32 32
Patient-Device Incompatibility 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
No Display/Image 25 25
Use of Device Problem 25 25
Misassembled 24 24
Physical Resistance/Sticking 24 24
Gel Leak 23 23
Defective Component 19 19
Inability to Irrigate 18 18
Restricted Flow rate 17 17
Insufficient Information 16 16
Material Protrusion/Extrusion 16 16
Naturally Worn 16 16
Defective Device 16 16
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
Therapeutic or Diagnostic Output Failure 8 8
Sharp Edges 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 3380 3380
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 357 357
No Patient Involvement 301 301
Pain 217 217
Urinary Tract Infection 154 154
Foreign Body In Patient 130 130
Patient Problem/Medical Problem 118 118
Hematuria 83 83
Discomfort 81 81
No Code Available 66 66
Insufficient Information 47 47
Unspecified Infection 36 36
Urinary Retention 35 35
Hemorrhage/Bleeding 25 25
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 13 13
Incontinence 12 12
Abdominal Distention 11 11
Exposure to Body Fluids 9 9
Abdominal Pain 8 8
Abrasion 8 8
Inflammation 8 8
Irritation 8 8
Unspecified Gastrointestinal Problem 8 8
Reaction 7 7
Distress 7 7
Tissue Damage 6 6
Irritability 6 6
Swelling 6 6
Skin Discoloration 5 5
Laceration(s) 5 5
Bacterial Infection 5 5
Erythema 5 5
Fever 5 5
Blood Loss 5 5
Pressure Sores 5 5
Swelling/ Edema 5 5
Cramp(s) /Muscle Spasm(s) 4 4
Localized Skin Lesion 3 3
Unspecified Tissue Injury 3 3
Anxiety 3 3
Burning Sensation 3 3
Injury 3 3
Micturition Urgency 3 3
Muscle Spasm(s) 3 3
Rash 3 3
Local Reaction 2 2
Sepsis 2 2
Thrombus 2 2
High Blood Pressure/ Hypertension 2 2
Calcium Deposits/Calcification 2 2
Depression 2 2
Inadequate Pain Relief 2 2
Obstruction/Occlusion 2 2
Skin Tears 2 2
Alteration In Body Temperature 2 2
Chills 2 2
Convulsion/Seizure 2 2
Not Applicable 2 2
Urethral Stenosis/Stricture 1 1
Genital Bleeding 1 1
Cramp(s) 1 1
Tingling 1 1
Ulceration 1 1
Uterine Perforation 1 1
Abnormal Vaginal Discharge 1 1
Discharge 1 1
Excessive Tear Production 1 1
Subclinical Infection 1 1
Sneezing 1 1
Urinary Frequency 1 1
Dysuria 1 1
Inadequate Osseointegration 1 1
Bowel Perforation 1 1
Confusion/ Disorientation 1 1
Spinal Cord Injury 1 1
Cyst(s) 1 1
Death 1 1
Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Hematoma 1 1
Skin Irritation 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Itching Sensation 1 1

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