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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 483 483

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 817 817
Fluid/Blood Leak 661 661
Deflation Problem 658 658
Difficult to Remove 605 605
Decrease in Pressure 497 497
Material Puncture/Hole 448 448
Failure to Infuse 382 382
Partial Blockage 278 278
Inaccurate Flow Rate 245 245
Material Fragmentation 206 206
Material Rupture 195 195
Adverse Event Without Identified Device or Use Problem 180 180
Erratic or Intermittent Display 158 158
Inflation Problem 156 156
Leak/Splash 155 155
Break 135 135
Material Split, Cut or Torn 131 131
Device Fell 124 124
Patient Device Interaction Problem 96 96
Device Sensing Problem 83 83
Device Dislodged or Dislocated 79 79
Biocompatibility 74 74
Component Misassembled 70 70
Device Slipped 70 70
Component Missing 69 69
Illegible Information 56 56
Inadequate or Insufficient Training 55 55
Disconnection 54 54
Obstruction of Flow 54 54
Material Invagination 52 52
Calcified 47 47
Incorrect Measurement 47 47
Material Deformation 44 44
No Flow 40 40
Detachment of Device or Device Component 39 39
Complete Blockage 39 39
Difficult to Insert 39 39
Device Contamination with Chemical or Other Material 38 38
Dent in Material 38 38
Device Handling Problem 36 36
Material Twisted/Bent 34 34
Deformation Due to Compressive Stress 34 34
Inadequate Instructions for Healthcare Professional 33 33
Tear, Rip or Hole in Device Packaging 32 32
Patient-Device Incompatibility 31 31
Short Fill 31 31
Missing Information 29 29
Nonstandard Device 27 27
Fracture 26 26
No Display/Image 26 26
Use of Device Problem 25 25
Misassembled 24 24
Physical Resistance/Sticking 24 24
Gel Leak 23 23
Inability to Irrigate 21 21
Defective Component 19 19
Restricted Flow rate 17 17
Defective Device 17 17
Insufficient Information 16 16
Material Protrusion/Extrusion 16 16
Naturally Worn 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
Wrong Label 5 5
Failure to Deflate 4 4
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3536 3536
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 367 367
No Patient Involvement 301 301
Pain 222 222
Urinary Tract Infection 157 157
Foreign Body In Patient 138 138
Patient Problem/Medical Problem 118 118
Hematuria 84 84
Discomfort 83 83
No Code Available 66 66
Insufficient Information 48 48
Unspecified Infection 37 37
Urinary Retention 35 35
Hemorrhage/Bleeding 25 25
Tissue Breakdown 23 23
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
Skin Discoloration 6 6
Swelling 6 6
Swelling/ Edema 6 6
Unspecified Tissue Injury 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Laceration(s) 5 5
Bacterial Infection 5 5
Erythema 5 5
Fever 5 5
Blood Loss 5 5
Pressure Sores 5 5
Localized Skin Lesion 4 4
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
Neuropathy 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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