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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, straight
Product CodeEZD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAPTA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
AMSINO INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTRA TECH AB
  SUBSTANTIALLY EQUIVALENT 1
ASTRA TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIG BLUE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONREE MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 4
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US, LLC
  SUBSTANTIALLY EQUIVALENT 1
COMPACTCATH INC
  SUBSTANTIALLY EQUIVALENT 1
COMPACTCATH INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPACTCATH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
CURE MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHESTER MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WELLSPECT HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ZHANJIANG STAR ENTERPRISE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 17 17
2015 21 21
2016 21 21
2017 120 120
2018 390 390
2019 466 466
2020 563 563
2021 994 994
2022 486 486
2023 555 555
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 672 672
Defective Device 577 577
Product Quality Problem 484 484
Improper Chemical Reaction 340 340
Difficult to Insert 286 286
Sharp Edges 172 172
Patient-Device Incompatibility 159 159
Difficult to Remove 156 156
Biocompatibility 151 151
Material Integrity Problem 147 147
Incorrect Measurement 140 140
Material Twisted/Bent 113 113
Component Misassembled 102 102
Component Missing 91 91
Inaccurate Flow Rate 66 66
Device Damaged Prior to Use 65 65
Inadequacy of Device Shape and/or Size 64 64
Misassembled 53 53
Nonstandard Device 52 52
Insufficient Information 52 52
Material Fragmentation 51 51
Difficult to Open or Close 43 43
Unsealed Device Packaging 35 35
Material Deformation 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Contamination /Decontamination Problem 31 31
Appropriate Term/Code Not Available 31 31
Scratched Material 31 31
Device Operates Differently Than Expected 30 30
Therapeutic or Diagnostic Output Failure 28 28
Device Handling Problem 28 28
No Flow 27 27
Delivered as Unsterile Product 26 26
Fluid/Blood Leak 24 24
Material Protrusion/Extrusion 23 23
Defective Component 18 18
Partial Blockage 17 17
Patient Device Interaction Problem 17 17
Leak/Splash 16 16
Use of Device Problem 16 16
Break 15 15
Bent 12 12
Tear, Rip or Hole in Device Packaging 12 12
Structural Problem 12 12
Material Too Rigid or Stiff 12 12
Physical Resistance/Sticking 12 12
Obstruction of Flow 12 12
Inadequate Instructions for Healthcare Professional 11 11
Short Fill 10 10
Material Too Soft/Flexible 10 10
Moisture or Humidity Problem 9 9
Material Split, Cut or Torn 8 8
Improper or Incorrect Procedure or Method 8 8
Deformation Due to Compressive Stress 7 7
Device Markings/Labelling Problem 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Device Contamination with Chemical or Other Material 7 7
Difficult to Open or Remove Packaging Material 6 6
Infusion or Flow Problem 6 6
Off-Label Use 6 6
Kinked 6 6
Material Puncture/Hole 5 5
Device Inoperable 5 5
Incomplete or Missing Packaging 5 5
Detachment of Device or Device Component 5 5
Device Ingredient or Reagent Problem 4 4
Packaging Problem 4 4
Inadequate Lubrication 4 4
Illegible Information 4 4
Out-Of-Box Failure 4 4
Material Separation 4 4
Shipping Damage or Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Fracture 4 4
Mechanical Problem 3 3
Device Emits Odor 3 3
Burst Container or Vessel 3 3
Contamination 3 3
Disconnection 3 3
Restricted Flow rate 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Advance 3 3
Missing Information 3 3
Positioning Problem 3 3
Output Problem 3 3
No Apparent Adverse Event 3 3
Improper Flow or Infusion 3 3
Difficult to Advance 2 2
Blocked Connection 2 2
Cut In Material 2 2
Protective Measures Problem 2 2
Dull, Blunt 2 2
Microbial Contamination of Device 2 2
Device Slipped 2 2
Sticking 2 2
Detachment Of Device Component 2 2
Flaked 2 2
Crack 2 2
Deflation Problem 2 2
Positioning Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1320 1320
Urinary Tract Infection 832 832
No Consequences Or Impact To Patient 673 673
No Known Impact Or Consequence To Patient 606 606
Pain 232 232
Hemorrhage/Bleeding 185 185
Patient Problem/Medical Problem 156 156
Discomfort 126 126
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 122 122
No Patient Involvement 99 99
Unspecified Infection 84 84
Hematuria 35 35
Abrasion 34 34
Blood Loss 33 33
No Code Available 31 31
No Information 29 29
Sepsis 29 29
Irritation 29 29
Burning Sensation 22 22
Injury 16 16
Laceration(s) 16 16
Unspecified Tissue Injury 14 14
Tissue Damage 10 10
Hypersensitivity/Allergic reaction 9 9
Fever 8 8
Urinary Retention 8 8
Tissue Breakdown 8 8
Insufficient Information 8 8
Irritability 7 7
Skin Irritation 7 7
Bacterial Infection 6 6
Skin Tears 5 5
Fungal Infection 4 4
Nausea 4 4
Rash 4 4
Bruise/Contusion 3 3
Headache 3 3
Swelling 3 3
Thrombus 3 3
Vomiting 3 3
Genital Bleeding 3 3
Skin Inflammation/ Irritation 3 3
Confusion/ Disorientation 3 3
Foreign Body In Patient 3 3
Missing Value Reason 2 2
Uterine Perforation 2 2
Abdominal Cramps 2 2
Dysuria 2 2
Hypernatremia 2 2
Hyperglycemia 2 2
Death 2 2
Local Reaction 2 2
Scar Tissue 2 2
Pneumonia 2 2
Inflammation 2 2
Muscle Spasm(s) 2 2
Itching Sensation 1 1
Low Blood Pressure/ Hypotension 1 1
Internal Organ Perforation 1 1
Scarring 1 1
Renal Failure 1 1
Dehydration 1 1
Diarrhea 1 1
Erythema 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Atrial Fibrillation 1 1
Abdominal Pain 1 1
Cyst(s) 1 1
Foreign Body Sensation in Eye 1 1
Urinary Frequency 1 1
Urticaria 1 1
Obstruction/Occlusion 1 1
Malaise 1 1
Reaction 1 1
Sleep Dysfunction 1 1
Perforation of Vessels 1 1
Chills 1 1
Cramp(s) 1 1
Rupture 1 1
Tachycardia 1 1
Thrombosis 1 1
Septic Shock 1 1
Cancer 1 1
Dementia 1 1
Syncope/Fainting 1 1
Kidney Infection 1 1
Unspecified Kidney or Urinary Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Urinary Incontinence 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jun-08-2023
2 C.R. Bard, Inc. II Apr-04-2018
3 Coloplast Manufacturing US, LLC II Jun-03-2011
4 Cure Medical LLC II Dec-16-2014
5 Cure Medical LLC II Oct-02-2012
6 Wellspect HealthCare (Division of DENTSPLY IH AB) II Jul-17-2020
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