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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 INNOVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 7
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BEIJING FERT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R BARD, INC.
  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 3
INNOVATIVE HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, 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 3
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
TOPSPINS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 5
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 8460 8460
2017 6459 6459
2018 6567 6567
2019 11214 11214
2020 9551 9551
2021 7132 7133

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 16295 16295
Leak/Splash 6616 6616
Detachment of Device or Device Component 2831 2831
Disconnection 2755 2755
Break 2436 2436
Material Separation 1898 1898
Crack 1657 1657
Device Alarm System 1297 1297
Complete Blockage 1261 1262
Failure To Adhere Or Bond 1029 1029
No Flow 1006 1006
Device Displays Incorrect Message 942 942
Infusion or Flow Problem 926 926
Insufficient Flow or Under Infusion 886 886
Device Operates Differently Than Expected 859 859
Material Twisted/Bent 804 804
Restricted Flow rate 782 782
Device Contamination with Chemical or Other Material 763 763
Material Deformation 670 670
Loss of or Failure to Bond 661 661
Failure to Prime 626 626
Free or Unrestricted Flow 584 584
Detachment Of Device Component 572 572
Bent 558 558
Improper Flow or Infusion 512 512
Reflux within Device 504 504
Backflow 484 484
Adverse Event Without Identified Device or Use Problem 476 476
Obstruction of Flow 470 470
Connection Problem 458 458
Material Puncture/Hole 360 360
Occlusion Within Device 320 320
Filling Problem 302 302
Hole In Material 287 287
Insufficient Information 274 274
Excess Flow or Over-Infusion 269 269
Loose or Intermittent Connection 268 268
Mechanical Problem 250 250
Failure to Infuse 233 233
Material Split, Cut or Torn 229 229
Failure to Deliver 216 216
Physical Resistance/Sticking 214 214
Component Missing 209 209
Kinked 196 196
Partial Blockage 195 195
Protective Measures Problem 159 159
Device Dislodged or Dislocated 150 150
Contamination /Decontamination Problem 149 149
Defective Device 148 148
Material Fragmentation 146 146
Tear, Rip or Hole in Device Packaging 141 141
Output Problem 140 140
Stretched 138 138
Material Integrity Problem 135 135
Material Rupture 135 135
Defective Component 132 132
Failure to Disconnect 125 125
Packaging Problem 121 121
Air Leak 119 119
Audible Prompt/Feedback Problem 118 118
Sticking 118 118
Inaccurate Delivery 114 114
Fitting Problem 103 103
Separation Failure 100 100
Improper or Incorrect Procedure or Method 98 98
Activation Problem 96 96
Appropriate Term/Code Not Available 88 88
False Alarm 83 83
Fracture 80 80
Deformation Due to Compressive Stress 78 78
Difficult to Remove 71 71
Retraction Problem 63 63
Flushing Problem 63 63
Manufacturing, Packaging or Shipping Problem 60 60
Gas Leak 59 59
Cut In Material 57 57
Unsealed Device Packaging 56 56
Product Quality Problem 56 56
Pressure Problem 55 55
Air/Gas in Device 55 55
Difficult to Flush 53 53
Device Operational Issue 53 53
Device Slipped 48 48
Use of Device Problem 48 48
Device Damaged Prior to Use 48 48
Volume Accuracy Problem 46 46
No Apparent Adverse Event 46 46
Chemical Spillage 45 45
Separation Problem 44 44
Failure to Sense 42 42
Device Markings/Labelling Problem 42 42
Contamination 42 42
Inaccurate Flow Rate 40 40
Incomplete or Inadequate Connection 40 40
Fail-Safe Did Not Operate 37 37
Delivered as Unsterile Product 37 37
Migration or Expulsion of Device 37 37
Difficult or Delayed Activation 35 35
Material Discolored 34 34
Fail-Safe Problem 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 18766 18775
No Known Impact Or Consequence To Patient 10403 10403
No Clinical Signs, Symptoms or Conditions 5232 5233
Hyperglycemia 4279 4279
No Patient Involvement 3959 3961
No Information 2902 2904
Diabetic Ketoacidosis 954 954
Insufficient Information 942 942
Chemical Exposure 506 506
Blood Loss 311 311
Device Embedded In Tissue or Plaque 230 230
Hypoglycemia 187 187
No Code Available 185 185
Unspecified Infection 184 184
Low Blood Pressure/ Hypotension 159 159
Underdose 152 152
Complaint, Ill-Defined 147 147
Needle Stick/Puncture 127 127
Inadequate Pain Relief 115 115
Pain 115 115
Death 96 96
Therapeutic Response, Decreased 93 93
Hemorrhage/Bleeding 68 68
Inflammation 65 65
Not Applicable 63 63
Dyspnea 61 61
Erythema 58 58
Vomiting 53 53
High Blood Pressure/ Hypertension 51 51
Foreign Body In Patient 51 51
Exposure to Body Fluids 50 50
Coma 48 48
Patient Problem/Medical Problem 45 45
Fever 44 44
Nausea 43 43
Bacterial Infection 42 42
Skin Irritation 39 39
Air Embolism 37 37
Fatigue 36 36
Headache 35 35
Missed Dose 32 32
Swelling 31 31
Rash 31 31
Cardiac Arrest 30 30
Venipuncture 29 29
Reaction, Injection Site 29 29
Overdose 27 27
Loss of consciousness 26 26
Injury 26 26
Malaise 26 26
Skin Inflammation 22 22
Chest Tightness/Pressure 22 22
Discomfort 22 22
Irritation 21 21
Bradycardia 20 20
Low Oxygen Saturation 20 20
Local Reaction 19 19
Tissue Damage 18 18
Tachycardia 17 17
Sepsis 17 17
Hepatitis 17 17
Hypersensitivity/Allergic reaction 16 16
Hypoxia 16 16
Respiratory Distress 15 15
Therapeutic Effects, Unexpected 15 15
Dizziness 14 14
Infiltration into Tissue 14 14
Diarrhea 14 14
Extravasation 13 13
Cellulitis 13 13
Abscess 13 13
Anxiety 13 13
Reaction 13 13
Apnea 12 12
Cardiopulmonary Arrest 11 11
Burning Sensation 11 11
Dehydration 10 10
Lethargy 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Skin Discoloration 9 9
Weakness 9 9
Neurological Deficit/Dysfunction 8 8
Seizures 8 8
Chest Pain 8 8
Hemolysis 8 8
Skin Inflammation/ Irritation 8 8
Injection Site Reaction 8 8
Therapeutic Response, Increased 8 8
Test Result 7 7
Edema 7 7
Bruise/Contusion 7 7
Chills 7 7
Heart Failure 7 7
Electrolyte Imbalance 7 7
Brain Injury 6 6
Itching Sensation 6 6
Stroke/CVA 6 6
Abdominal Pain 6 6
Eye Injury 6 6
Embolus 6 6

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 Jul-23-2021
4 B. Braun Medical, Inc. II Apr-29-2021
5 B. Braun Medical, Inc. II Feb-02-2020
6 B. Braun Medical, Inc. I Sep-23-2019
7 B. Braun Medical, Inc. II Jun-25-2018
8 BD SWITZERLAND SARL II May-13-2020
9 Bard Access Systems II Jan-10-2017
10 Baxter Healthcare Corp. II Aug-29-2016
11 Baxter Healthcare Corp. II Jan-07-2016
12 Baxter Healthcare Corporation II Feb-09-2021
13 Baxter Healthcare Corporation II Jan-09-2020
14 Bayer Medical Care, Inc. II Oct-11-2018
15 Becton Dickinson & Company II Nov-04-2019
16 Becton Dickinson & Company II Oct-07-2019
17 Becton Dickinson & Company I Jul-11-2019
18 Becton Dickinson & Company I Jun-26-2019
19 Becton Dickinson & Company II Apr-10-2019
20 Becton Dickinson & Company II Nov-04-2018
21 Becton Dickinson & Company II May-01-2017
22 CAREFUSION II Sep-13-2021
23 CAREFUSION II Jul-01-2021
24 CME America, LLC I Jul-15-2020
25 CME America, LLC II May-04-2020
26 CareFusion 303, Inc. II Nov-04-2018
27 CareFusion 303, Inc. II Jun-07-2018
28 CareFusion 303, Inc. II Aug-11-2017
29 CareFusion 303, Inc. II Apr-27-2017
30 CareFusion 303, Inc. II Feb-28-2017
31 CareFusion 303, Inc. II Feb-28-2017
32 CareFusion 303, Inc. II Mar-17-2016
33 Centurion Medical Products Corporation II Feb-23-2016
34 Codan US Corporation II Jun-26-2020
35 ConMed Corporation II Feb-28-2018
36 Global Healthcare Inc II Feb-03-2016
37 Hospira Inc. II Jun-29-2016
38 ICU Medical, Inc. II May-13-2021
39 ICU Medical, Inc. II Dec-23-2020
40 ICU Medical, Inc. II Oct-22-2020
41 ICU Medical, Inc. II May-06-2020
42 ICU Medical, Inc. I Apr-15-2019
43 ICU Medical, Inc. II Jan-10-2017
44 Medtronic Inc. II Jul-05-2018
45 Medtronic Inc. II Nov-18-2017
46 Merit Medical Systems, Inc. II Nov-21-2016
47 Molded Products Inc II Aug-22-2019
48 Repro-Med Systems, Inc. II Oct-07-2019
49 Repro-Med Systems, Inc. II Jan-05-2018
50 Rymed Technologies, LLC II Jan-21-2016
51 Smiths Medical ASD Inc. II Oct-24-2019
52 Smiths Medical ASD Inc. II Oct-11-2018
53 Smiths Medical ASD Inc. II Jul-24-2017
54 Smiths Medical ASD Inc. II Mar-30-2017
55 Smiths Medical ASD, Inc. II May-27-2016
56 Unomedical As II Nov-03-2016
57 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
58 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
59 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Dec-18-2016
60 Vygon U.S.A. II Apr-09-2019
61 WalkMed Infusion, LLC II Jul-18-2016
62 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
63 Zyno Medical LLC II Jul-23-2019
64 Zyno Medical LLC II Sep-27-2016
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