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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
BIG BLUE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONREE MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 592 592
Defective Device 573 573
Improper Chemical Reaction 340 340
Product Quality Problem 269 269
Difficult to Insert 226 226
Sharp Edges 172 172
Biocompatibility 151 151
Difficult to Remove 148 148
Incorrect Measurement 130 130
Component Misassembled 102 102
Patient-Device Incompatibility 96 96
Material Twisted/Bent 92 92
Inadequacy of Device Shape and/or Size 62 62
Component Missing 62 62
Material Integrity Problem 55 55
Material Fragmentation 51 51
Inaccurate Flow Rate 49 49
Misassembled 44 44
Device Damaged Prior to Use 44 44
Difficult to Open or Close 42 42
Nonstandard Device 36 36
Unsealed Device Packaging 35 35
Contamination /Decontamination Problem 31 31
Insufficient Information 30 30
Manufacturing, Packaging or Shipping Problem 29 29
Therapeutic or Diagnostic Output Failure 28 28
Device Handling Problem 28 28
Delivered as Unsterile Product 26 26
Material Deformation 24 24
Material Protrusion/Extrusion 21 21
Scratched Material 21 21
Fluid/Blood Leak 21 21
Defective Component 17 17
Patient Device Interaction Problem 17 17
No Flow 15 15
Use of Device Problem 13 13
Structural Problem 12 12
Obstruction of Flow 11 11
Leak/Splash 11 11
Material Too Soft/Flexible 10 10
Appropriate Term/Code Not Available 9 9
Physical Resistance/Sticking 9 9
Partial Blockage 9 9
Short Fill 9 9
Tear, Rip or Hole in Device Packaging 8 8
Improper or Incorrect Procedure or Method 8 8
Break 8 8
Inadequate Instructions for Healthcare Professional 8 8
Material Too Rigid or Stiff 8 8
Device Misassembled During Manufacturing /Shipping 7 7
Material Split, Cut or Torn 7 7
Device Markings/Labelling Problem 6 6
Difficult to Open or Remove Packaging Material 6 6
Incomplete or Missing Packaging 5 5
Off-Label Use 5 5
Infusion or Flow Problem 5 5
Inadequate Lubrication 4 4
Illegible Information 4 4
Shipping Damage or Problem 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Deformation Due to Compressive Stress 3 3
Contamination 3 3
Disconnection 3 3
Fracture 3 3
Labelling, Instructions for Use or Training Problem 3 3
Missing Information 3 3
No Apparent Adverse Event 3 3
Output Problem 3 3
Improper Flow or Infusion 2 2
Flaked 2 2
Restricted Flow rate 2 2
Deflation Problem 2 2
Material Separation 2 2
Dull, Blunt 2 2
Insufficient Flow or Under Infusion 2 2
Device Slipped 2 2
Inadequate or Insufficient Training 1 1
Unstable 1 1
Fitting Problem 1 1
Material Perforation 1 1
Blocked Connection 1 1
Failure to Advance 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Device Sensing Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Positioning Failure 1 1
Crack 1 1
Complete Blockage 1 1
Collapse 1 1
Flushing Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1320 1320
Urinary Tract Infection 740 740
No Consequences Or Impact To Patient 489 489
No Known Impact Or Consequence To Patient 393 393
Pain 180 180
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 122 122
Hemorrhage/Bleeding 118 118
Patient Problem/Medical Problem 105 105
Discomfort 87 87
Unspecified Infection 73 73
No Patient Involvement 68 68
Abrasion 32 32
Sepsis 25 25
No Code Available 24 24
Blood Loss 20 20
Hematuria 19 19
Irritation 15 15
Burning Sensation 14 14
Unspecified Tissue Injury 14 14
Injury 10 10
Laceration(s) 9 9
Tissue Breakdown 8 8
Insufficient Information 8 8
Irritability 7 7
Tissue Damage 6 6
Urinary Retention 6 6
Skin Irritation 6 6
Bacterial Infection 6 6
Fever 6 6
Hypersensitivity/Allergic reaction 5 5
Skin Tears 5 5
No Information 5 5
Nausea 4 4
Rash 4 4
Bruise/Contusion 3 3
Vomiting 3 3
Fungal Infection 3 3
Confusion/ Disorientation 3 3
Headache 3 3
Thrombus 3 3
Genital Bleeding 3 3
Skin Inflammation/ Irritation 3 3
Hypernatremia 2 2
Abdominal Cramps 2 2
Dysuria 2 2
Death 2 2
Hyperglycemia 2 2
Local Reaction 2 2
Swelling 2 2
Pneumonia 2 2
Septic Shock 1 1
Tachycardia 1 1
Thrombosis 1 1
Renal Failure 1 1
Scar Tissue 1 1
Scarring 1 1
Internal Organ Perforation 1 1
Foreign Body Sensation in Eye 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Dehydration 1 1
Diarrhea 1 1
Erythema 1 1
Cyst(s) 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Foreign Body In Patient 1 1
Cancer 1 1
Dementia 1 1
Syncope/Fainting 1 1
Kidney Infection 1 1
Unspecified Kidney or Urinary Problem 1 1
Urinary Frequency 1 1
Rupture 1 1
Malaise 1 1
Reaction 1 1
Chills 1 1
Cramp(s) 1 1
Perforation of Vessels 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 Wellspect HealthCare (Division of DENTSPLY IH AB) II Jul-17-2020
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