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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device catheter, hemodialysis, non-implanted
Product CodeMPB
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
AMECO MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
C.R BARD INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R BARD. INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT - KIT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO RENAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 82 82
2015 51 51
2016 70 70
2017 86 86
2018 120 120
2019 119 119
2020 179 179
2021 192 192
2022 166 166
2023 204 204
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 175 175
Break 130 130
Difficult to Remove 102 102
Material Deformation 101 101
Fluid/Blood Leak 94 94
Material Frayed 90 90
Crack 82 82
Unraveled Material 76 76
Product Quality Problem 73 73
Deformation Due to Compressive Stress 66 66
Leak/Splash 65 65
Kinked 58 58
Physical Resistance/Sticking 44 44
Material Twisted/Bent 37 37
Obstruction of Flow 30 30
Physical Resistance 29 29
Material Separation 28 28
Migration or Expulsion of Device 26 26
Material Integrity Problem 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Component Incompatible 20 20
Detachment of Device or Device Component 20 20
Infusion or Flow Problem 19 19
Defective Component 18 18
Device Operates Differently Than Expected 17 17
Migration 17 17
Disconnection 14 14
Difficult to Insert 12 12
Loose or Intermittent Connection 11 11
Device Damaged Prior to Use 10 10
Difficult to Advance 10 10
Sticking 10 10
Bent 9 9
Device Markings/Labelling Problem 9 9
Failure to Infuse 9 9
Appropriate Term/Code Not Available 9 9
Failure to Advance 9 9
Contamination /Decontamination Problem 9 9
Hole In Material 9 9
Insufficient Flow or Under Infusion 9 9
Gas/Air Leak 9 9
Device Handling Problem 8 8
Fracture 8 8
Device Slipped 7 7
Material Split, Cut or Torn 7 7
Retraction Problem 6 6
Delivered as Unsterile Product 6 6
Insufficient Information 6 6
Improper or Incorrect Procedure or Method 6 6
Material Fragmentation 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 580 580
No Consequences Or Impact To Patient 311 311
No Known Impact Or Consequence To Patient 177 177
Insufficient Information 88 88
No Information 61 61
Blood Loss 41 41
No Patient Involvement 39 39
Needle Stick/Puncture 28 28
No Code Available 25 25
Hemorrhage/Bleeding 23 23
Foreign Body In Patient 17 17
Air Embolism 10 10
Hematoma 9 9
Unintended Radiation Exposure 8 8
Death 6 6
Radiation Exposure, Unintended 6 6
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pain 4 4
Swelling/ Edema 4 4
Low Blood Pressure/ Hypotension 4 4
Cardiac Arrest 4 4
Laceration(s) 3 3
Injury 3 3
Headache 3 3
Perforation 3 3
Exsanguination 3 3
Low Oxygen Saturation 3 3
Failure of Implant 3 3
Unspecified Infection 3 3
Anemia 2 2
Loss of consciousness 2 2
Reaction, Injection Site 2 2
Peritonitis 2 2
Skin Tears 2 2
Hemothorax 2 2
Decreased Respiratory Rate 2 2
Erythema 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 2 2
Bacterial Infection 1 1
Hypoxia 1 1
Perforation of Vessels 1 1
Anaphylactic Shock 1 1
Asystole 1 1
Reaction 1 1
Thrombus 1 1
Fistula 1 1
Pneumonia 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-10-2018
2 Arrow International Inc II Feb-20-2018
3 Arrow International Inc II Jun-12-2017
4 Cordis Corporation II Aug-18-2015
5 Medical Components, Inc dba MedComp II Aug-25-2018
6 Medtronic Minimally Invasive Therapies Group II Mar-14-2018
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