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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 4
  SUBSTANTIALLY EQUIVALENT - KIT 1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 6
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 3
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 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 683 683
Defective Device 579 579
Product Quality Problem 486 486
Improper Chemical Reaction 340 340
Difficult to Insert 286 286
Sharp Edges 193 193
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 115 115
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
Insufficient Information 53 53
Misassembled 53 53
Nonstandard Device 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
Patient Device Interaction Problem 17 17
Partial Blockage 17 17
Use of Device Problem 16 16
Break 16 16
Leak/Splash 16 16
Bent 12 12
Physical Resistance/Sticking 12 12
Obstruction of Flow 12 12
Material Too Rigid or Stiff 12 12
Tear, Rip or Hole in Device Packaging 12 12
Structural Problem 12 12
Inadequate Instructions for Healthcare Professional 11 11
Short Fill 10 10
Material Too Soft/Flexible 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1338 1338
Urinary Tract Infection 839 839
No Consequences Or Impact To Patient 673 673
No Known Impact Or Consequence To Patient 606 606
Pain 233 233
Hemorrhage/Bleeding 196 196
Patient Problem/Medical Problem 156 156
Discomfort 127 127
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 122 122
No Patient Involvement 99 99
Unspecified Infection 85 85
Hematuria 36 36
Abrasion 34 34
Blood Loss 33 33
No Code Available 31 31
Sepsis 29 29
No Information 29 29
Irritation 29 29
Burning Sensation 22 22
Laceration(s) 16 16
Injury 16 16
Unspecified Tissue Injury 14 14
Tissue Breakdown 10 10
Hypersensitivity/Allergic reaction 10 10
Tissue Damage 10 10
Insufficient Information 8 8
Urinary Retention 8 8
Fever 8 8
Irritability 7 7
Skin Irritation 7 7
Bacterial Infection 6 6
Skin Tears 5 5
Foreign Body In Patient 4 4
Rash 4 4
Genital Bleeding 4 4
Nausea 4 4
Fungal Infection 4 4
Confusion/ Disorientation 3 3
Bruise/Contusion 3 3
Thrombus 3 3
Swelling 3 3
Vomiting 3 3
Skin Inflammation/ Irritation 3 3
Headache 3 3
Uterine Perforation 2 2
Local Reaction 2 2
Muscle Spasm(s) 2 2
Abdominal Cramps 2 2
Inflammation 2 2
Hyperglycemia 2 2

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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