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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, retention type, balloon
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
APOLLON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK UROLOGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVALON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
EMMY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HR PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLIE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
PERCUVISION
  SUBSTANTIALLY EQUIVALENT 1
PERCUVISION LLC
  SUBSTANTIALLY EQUIVALENT 1
POIESIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
SAFE MEDICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
SEEDINGS LIFE SCIENCE VENTURES, LLC
  SUBSTANTIALLY EQUIVALENT 2
SILQ TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SILQ TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
THE FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
URETHROTECH
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 229 229
2015 303 303
2016 326 326
2017 571 571
2018 677 677
2019 670 670
2020 711 711
2021 701 701
2022 884 884
2023 775 775
2024 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 850 850
Burst Container or Vessel 788 788
Fluid/Blood Leak 621 621
Difficult to Remove 387 387
Break 359 359
Leak/Splash 326 326
Material Puncture/Hole 300 300
Decrease in Pressure 233 233
Material Rupture 213 213
Inflation Problem 200 200
Material Invagination 193 193
Material Split, Cut or Torn 148 148
Partial Blockage 145 145
Device Dislodged or Dislocated 144 144
Adverse Event Without Identified Device or Use Problem 128 128
Material Deformation 124 124
Failure to Infuse 114 114
Erratic or Intermittent Display 113 113
Component Missing 93 93
Device Operates Differently Than Expected 92 92
Mushroomed 87 87
Inaccurate Flow Rate 85 85
Material Fragmentation 79 79
Device Fell 74 74
Material Integrity Problem 71 71
Device Contamination with Chemical or Other Material 71 71
Hole In Material 70 70
Detachment of Device or Device Component 66 66
No Flow 64 64
Device Slipped 58 58
Obstruction of Flow 56 56
Component Falling 51 51
Failure to Deflate 44 44
Material Protrusion/Extrusion 43 43
Patient-Device Incompatibility 43 43
Defective Device 41 41
Incorrect Measurement 39 39
Patient Device Interaction Problem 39 39
Difficult to Insert 38 38
Component Misassembled 37 37
Insufficient Information 37 37
Unintended Deflation 35 35
Fracture 35 35
Detachment Of Device Component 34 34
Physical Resistance/Sticking 34 34
Material Twisted/Bent 33 33
Tear, Rip or Hole in Device Packaging 30 30
Complete Blockage 29 29
Crack 28 28
Dent in Material 25 25
Appropriate Term/Code Not Available 25 25
Device Damaged Prior to Use 24 24
Physical Resistance 24 24
Deformation Due to Compressive Stress 23 23
Temperature Problem 23 23
Occlusion Within Device 22 22
Bent 21 21
Biocompatibility 21 21
Split 20 20
Short Fill 20 20
Calcified 20 20
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Material Perforation 19 19
Device Markings/Labelling Problem 18 18
Restricted Flow rate 18 18
Manufacturing, Packaging or Shipping Problem 18 18
No Display/Image 17 17
Improper or Incorrect Procedure or Method 17 17
Material Too Rigid or Stiff 16 16
Misassembled 16 16
Nonstandard Device 15 15
Product Quality Problem 15 15
Inadequate Instructions for Healthcare Professional 14 14
Difficult to Advance 14 14
Infusion or Flow Problem 14 14
Device Contaminated During Manufacture or Shipping 13 13
Gas/Air Leak 13 13
Defective Component 13 13
Material Discolored 13 13
Entrapment of Device 12 12
Contamination 12 12
Gel Leak 12 12
Low Readings 12 12
Sharp Edges 12 12
Torn Material 11 11
Packaging Problem 11 11
Scratched Material 11 11
Inadequacy of Device Shape and/or Size 11 11
Material Separation 11 11
Failure to Advance 11 11
Off-Label Use 11 11
Disconnection 11 11
Use of Device Problem 10 10
Output Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Missing Information 9 9
Fitting Problem 9 9
Structural Problem 9 9
Contamination /Decontamination Problem 9 9
Folded 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2066 2066
No Known Impact Or Consequence To Patient 1678 1678
No Consequences Or Impact To Patient 1563 1563
Pain 371 371
No Patient Involvement 233 233
No Information 216 216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 186 186
Insufficient Information 175 175
Urinary Tract Infection 129 129
Discomfort 118 118
Hemorrhage/Bleeding 95 95
Urinary Retention 76 76
Foreign Body In Patient 74 74
Patient Problem/Medical Problem 72 72
Hematuria 71 71
No Code Available 62 62
Blood Loss 34 34
Injury 28 28
Unspecified Infection 27 27
Device Embedded In Tissue or Plaque 21 21
Genital Bleeding 14 14
Skin Inflammation/ Irritation 13 13
Tissue Damage 12 12
Burning Sensation 12 12
Inflammation 9 9
Irritation 8 8
Fever 8 8
Death 7 7
Sepsis 7 7
Perforation 6 6
Erosion 6 6
Unspecified Tissue Injury 6 6
Urinary Incontinence 6 6
Tissue Breakdown 6 6
Skin Tears 6 6
Alteration In Body Temperature 5 5
Incontinence 5 5
Laceration(s) 5 5
Muscle Spasm(s) 4 4
Internal Organ Perforation 4 4
Local Reaction 4 4
Swelling 4 4
Abdominal Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Exposure to Body Fluids 4 4
Abdominal Distention 4 4
Abdominal Cramps 4 4
Dysuria 3 3
Pressure Sores 3 3
Anxiety 3 3
Reaction 3 3
Sweating 3 3
Not Applicable 3 3
Cancer 3 3
High Blood Pressure/ Hypertension 3 3
Abrasion 3 3
Bacterial Infection 3 3
Cellulitis 3 3
Skin Discoloration 3 3
Thrombus 3 3
Discharge 3 3
Scar Tissue 3 3
Necrosis 3 3
Rash 2 2
Dizziness 2 2
Skin Irritation 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Fistula 2 2
Fatigue 2 2
Hematoma 2 2
Failure of Implant 2 2
Unspecified Gastrointestinal Problem 2 2
Obstruction/Occlusion 2 2
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 2 2
Diaphoresis 2 2
Impaired Healing 2 2
Distress 2 2
Fluid Discharge 2 2
Surgical procedure, additional 2 2
Fungal Infection 2 2
Irritability 1 1
Confusion/ Disorientation 1 1
Sleep Dysfunction 1 1
Therapy/non-surgical treatment, additional 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
Heart Failure 1 1
Rupture 1 1
Sedation 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Inadequate Pain Relief 1 1
Coma 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Respiratory Failure 1 1
Organ Dehiscence 1 1
Shaking/Tremors 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 C.R. Bard, Inc. II Sep-15-2016
3 Cardinal Health 200, LLC I Feb-16-2024
4 Coloplast Manufacturing US, LLC II Apr-20-2016
5 Covidien LLC II Mar-21-2016
6 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
7 Degania Silicone, Ltd. II Jan-13-2020
8 Degania Silicone, Ltd. II Sep-20-2018
9 Medline Industries Inc II May-18-2020
10 Nurse Assist, LLC I Dec-20-2023
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