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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, straight
Regulation Description Urological catheter and accessories.
Product CodeEZD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
BONREE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 5
CONVATEC
  SUBSTANTIALLY EQUIVALENT 2
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 4
HR HEALTHCARE
  SUBSTANTIALLY EQUIVALENT - KIT 1
JAMJOOM FULLCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELLSPECT AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 994 1003
2022 487 489
2023 553 554
2024 116 116
2025 291 291
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 532 532
Adverse Event Without Identified Device or Use Problem 429 430
Improper Chemical Reaction 298 298
Sharp Edges 209 209
Difficult to Remove 156 157
Component Misassembled 92 92
Product Quality Problem 86 86
Incorrect Measurement 73 73
Biocompatibility 72 72
Difficult to Insert 67 67
Material Twisted/Bent 53 53
Material Fragmentation 53 53
Unsealed Device Packaging 47 47
Difficult to Open or Close 41 41
Delivered as Unsterile Product 40 40
Contamination /Decontamination Problem 34 34
Device Handling Problem 30 31
Inaccurate Flow Rate 29 29
Patient Device Interaction Problem 28 28
Tear, Rip or Hole in Device Packaging 28 28
Insufficient Information 24 24
Nonstandard Device 24 24
Break 21 21
Material Protrusion/Extrusion 19 19
Inadequacy of Device Shape and/or Size 11 11
Component Missing 9 9
Fluid/Blood Leak 9 9
Defective Component 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Difficult to Open or Remove Packaging Material 8 8
Incomplete or Missing Packaging 7 7
Material Too Soft/Flexible 7 7
Material Disintegration 7 7
Material Integrity Problem 6 6
Short Fill 6 6
Patient-Device Incompatibility 5 5
Off-Label Use 5 5
Material Too Rigid or Stiff 5 5
Illegible Information 4 4
Partial Blockage 4 4
Material Split, Cut or Torn 4 4
Disconnection 4 4
Device Contamination with Chemical or Other Material 4 4
Device Ingredient or Reagent Problem 4 4
Inadequate Instructions for Healthcare Professional 3 3
Leak/Splash 3 3
Material Separation 3 3
No Apparent Adverse Event 3 3
Deformation Due to Compressive Stress 3 3
Physical Resistance/Sticking 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1473 1475
Urinary Tract Infection 540 542
Pain 173 173
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 143 143
Hemorrhage/Bleeding 87 87
Discomfort 65 65
Unspecified Infection 50 50
No Consequences Or Impact To Patient 36 36
Sepsis 23 23
Unspecified Tissue Injury 19 19
Abrasion 19 19
Tissue Breakdown 11 11
Hematuria 10 10
Burning Sensation 10 10
Genital Bleeding 8 8
Skin Inflammation/ Irritation 8 8
No Patient Involvement 8 8
Rash 8 8
No Code Available 7 7
Irritability 7 7
Fever 7 7
Skin Tears 6 6
Foreign Body In Patient 6 6
Hypersensitivity/Allergic reaction 4 4
Bacterial Infection 4 4
Bruise/Contusion 3 4
Headache 3 3
Laceration(s) 3 3
Local Reaction 3 3
Nausea 3 3
Fungal Infection 3 3
Chills 2 2
Anemia 2 2
Insufficient Information 2 10
Vomiting 2 2
Swelling/ Edema 2 2
Inflammation 2 2
Abdominal Cramps 2 2
Dysuria 2 2
Cancer 2 2
Confusion/ Disorientation 1 1
Localized Skin Lesion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Itching Sensation 1 1
Obstruction/Occlusion 1 1
Urinary Retention 1 1
Septic Shock 1 1
Diarrhea 1 1
Erythema 1 1
Alteration in Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jun-08-2023
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