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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, administration, intravascular
Regulation Description Intravascular administration set.
Product CodeFPA
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
410 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM A.S.
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM AS.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FERT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAIR L.G.L
  SUBSTANTIALLY EQUIVALENT 2
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
DOUGLAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVENIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGBAO MEDICAL EXPERIMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSAFETY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
PURACATH MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
RYMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 4
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 6459 6459
2018 6567 6567
2019 11214 11214
2020 9553 9553
2021 10387 10388

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 14623 14623
Leak/Splash 6371 6371
Detachment of Device or Device Component 3023 3023
Disconnection 2215 2215
Break 2180 2180
Material Separation 1739 1739
Device Alarm System 1700 1700
Complete Blockage 1490 1491
Crack 1332 1332
Insufficient Flow or Under Infusion 1009 1009
Restricted Flow rate 958 958
Infusion or Flow Problem 907 907
Material Twisted/Bent 874 874
Device Contamination with Chemical or Other Material 799 799
No Flow 759 759
Loss of or Failure to Bond 662 662
Free or Unrestricted Flow 587 587
Material Deformation 579 579
Backflow 511 511
Obstruction of Flow 477 477
Failure to Prime 463 463
Improper Flow or Infusion 452 452
Failure To Adhere Or Bond 402 402
Adverse Event Without Identified Device or Use Problem 381 381
Material Puncture/Hole 380 380
Device Operates Differently Than Expected 372 372
Connection Problem 365 365
Bent 360 360
Reflux within Device 312 312
Device Displays Incorrect Message 292 292
Filling Problem 283 283
Mechanical Problem 259 259
Excess Flow or Over-Infusion 257 257
Insufficient Information 251 251
Loose or Intermittent Connection 243 243
Material Split, Cut or Torn 240 240
Physical Resistance/Sticking 218 218
Detachment Of Device Component 189 189
Output Problem 189 189
Hole In Material 182 182
Audible Prompt/Feedback Problem 178 178
Occlusion Within Device 173 173
Defective Device 160 160
Component Missing 160 160
Contamination /Decontamination Problem 159 159
Tear, Rip or Hole in Device Packaging 149 149
Protective Measures Problem 144 144
Defective Component 141 141
Kinked 122 122
Material Fragmentation 120 120
Stretched 119 119
Inaccurate Delivery 117 117
Partial Blockage 115 115
Failure to Infuse 111 111
Failure to Disconnect 109 109
Activation Problem 106 106
Device Dislodged or Dislocated 102 102
Packaging Problem 99 99
Failure to Deliver 94 94
Material Integrity Problem 92 92
Improper or Incorrect Procedure or Method 91 91
Appropriate Term/Code Not Available 88 88
Air/Gas in Device 88 88
Material Rupture 86 86
Fitting Problem 83 83
False Alarm 81 81
Fracture 70 70
Separation Failure 68 68
Difficult to Remove 67 67
Pressure Problem 62 62
Manufacturing, Packaging or Shipping Problem 60 60
Failure to Sense 60 60
Gas Leak 59 59
Flushing Problem 57 57
Unsealed Device Packaging 56 56
Difficult to Flush 55 55
Retraction Problem 54 54
Volume Accuracy Problem 50 50
Deformation Due to Compressive Stress 50 50
Inaccurate Flow Rate 49 49
Air Leak 49 49
Device Damaged Prior to Use 48 48
Separation Problem 47 47
Device Markings/Labelling Problem 46 46
Incomplete or Inadequate Connection 45 45
Contamination 44 44
Use of Device Problem 39 39
Delivered as Unsterile Product 39 39
Fail-Safe Did Not Operate 39 39
No Apparent Adverse Event 35 35
Therapeutic or Diagnostic Output Failure 34 34
Difficult or Delayed Activation 34 34
Increase in Pressure 33 33
Difficult or Delayed Separation 32 32
Product Quality Problem 31 31
Cut In Material 30 30
Patient Device Interaction Problem 30 30
Priming Problem 30 30
Device Difficult to Setup or Prepare 29 29
Material Discolored 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16350 16359
No Clinical Signs, Symptoms or Conditions 7838 7839
No Known Impact Or Consequence To Patient 7378 7378
No Patient Involvement 3223 3225
No Information 2796 2798
Hyperglycemia 2753 2753
Insufficient Information 1220 1220
Diabetic Ketoacidosis 983 983
Chemical Exposure 507 507
Blood Loss 260 260
Unspecified Infection 156 156
Complaint, Ill-Defined 146 146
Underdose 142 142
Device Embedded In Tissue or Plaque 136 136
No Code Available 135 135
Low Blood Pressure/ Hypotension 133 133
Hypoglycemia 126 126
Inadequate Pain Relief 113 113
Needle Stick/Puncture 105 105
Pain 103 103
Therapeutic Response, Decreased 84 84
Death 78 78
Hemorrhage/Bleeding 67 67
Not Applicable 62 62
Dyspnea 53 53
Exposure to Body Fluids 50 50
Inflammation 50 50
High Blood Pressure/ Hypertension 44 44
Fever 43 43
Vomiting 43 43
Patient Problem/Medical Problem 40 40
Nausea 39 39
Bacterial Infection 38 38
Foreign Body In Patient 34 34
Coma 33 33
Erythema 32 32
Air Embolism 31 31
Rash 30 30
Missed Dose 30 30
Skin Irritation 29 29
Venipuncture 28 28
Headache 27 27
Reaction, Injection Site 27 27
Cardiac Arrest 26 26
Loss of consciousness 25 25
Injury 24 24
Swelling 23 23
Fatigue 23 23
Overdose 20 20
Hypersensitivity/Allergic reaction 19 19
Skin Inflammation 18 18
Low Oxygen Saturation 18 18
Discomfort 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Hepatitis 17 17
Bradycardia 17 17
Tissue Damage 17 17
Tachycardia 15 15
Therapeutic Effects, Unexpected 15 15
Hypoxia 15 15
Diarrhea 15 15
Respiratory Distress 14 14
Sepsis 14 14
Dizziness 14 14
Skin Inflammation/ Irritation 14 14
Cellulitis 13 13
Abscess 12 12
Apnea 12 12
Infiltration into Tissue 12 12
Extravasation 11 11
Burning Sensation 10 10
Irritation 10 10
Injection Site Reaction 10 10
Lethargy 9 9
Weakness 9 9
Anxiety 9 9
Reaction 9 9
Dehydration 9 9
Hematoma 8 8
Hemolysis 8 8
Therapeutic Response, Increased 8 8
Skin Discoloration 8 8
Seizures 8 8
Neurological Deficit/Dysfunction 8 8
Malaise 7 7
Electrolyte Imbalance 7 7
Bruise/Contusion 7 7
Chest Tightness/Pressure 7 7
Respiratory Failure 6 6
Increased Respiratory Rate 6 6
Shaking/Tremors 6 6
Tissue Breakdown 6 6
Test Result 6 6
Cardiopulmonary Arrest 6 6
Brain Injury 6 6
Chills 6 6
Local Reaction 6 6
Skin Erosion 5 5
Irritability 5 5
Stroke/CVA 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Mar-29-2017
2 B Braun Medical Inc II May-23-2017
3 B. Braun Medical, Inc. II Sep-24-2021
4 B. Braun Medical, Inc. II Jul-23-2021
5 B. Braun Medical, Inc. II Apr-29-2021
6 B. Braun Medical, Inc. II Feb-02-2020
7 B. Braun Medical, Inc. I Sep-23-2019
8 B. Braun Medical, Inc. II Jun-25-2018
9 BD SWITZERLAND SARL II May-13-2020
10 Bard Access Systems II Jan-10-2017
11 Baxter Healthcare Corporation II Feb-09-2021
12 Baxter Healthcare Corporation II Jan-09-2020
13 Bayer Medical Care, Inc. II Oct-11-2018
14 Becton Dickinson & Company II Nov-04-2019
15 Becton Dickinson & Company II Oct-07-2019
16 Becton Dickinson & Company I Jul-11-2019
17 Becton Dickinson & Company I Jun-26-2019
18 Becton Dickinson & Company II Apr-10-2019
19 Becton Dickinson & Company II Nov-04-2018
20 Becton Dickinson & Company II May-01-2017
21 CAREFUSION II Sep-13-2021
22 CAREFUSION II Jul-01-2021
23 CME America, LLC I Jul-15-2020
24 CME America, LLC II May-04-2020
25 CareFusion 303, Inc. II Nov-04-2018
26 CareFusion 303, Inc. II Jun-07-2018
27 CareFusion 303, Inc. II Aug-11-2017
28 CareFusion 303, Inc. II Apr-27-2017
29 CareFusion 303, Inc. II Feb-28-2017
30 CareFusion 303, Inc. II Feb-28-2017
31 Codan US Corporation II Jun-26-2020
32 ConMed Corporation II Feb-28-2018
33 ICU Medical, Inc. II May-13-2021
34 ICU Medical, Inc. II Dec-23-2020
35 ICU Medical, Inc. II Oct-22-2020
36 ICU Medical, Inc. II May-06-2020
37 ICU Medical, Inc. I Apr-15-2019
38 ICU Medical, Inc. II Jan-10-2017
39 Medtronic Inc. II Jul-05-2018
40 Medtronic Inc. II Nov-18-2017
41 Molded Products Inc II Aug-22-2019
42 Repro-Med Systems, Inc. II Oct-07-2019
43 Repro-Med Systems, Inc. II Jan-05-2018
44 Smiths Medical ASD Inc. II Oct-19-2021
45 Smiths Medical ASD Inc. II Oct-24-2019
46 Smiths Medical ASD Inc. II Oct-11-2018
47 Smiths Medical ASD Inc. II Jul-24-2017
48 Smiths Medical ASD Inc. II Mar-30-2017
49 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
50 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
51 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
52 Vygon U.S.A. II Apr-09-2019
53 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
54 Zyno Medical LLC II Jul-23-2019
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