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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 4
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
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
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 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 9553 9553
2021 8631 8632

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 16562 16562
Leak/Splash 6975 6975
Detachment of Device or Device Component 3046 3046
Disconnection 2794 2794
Break 2480 2480
Material Separation 1911 1911
Crack 1678 1678
Complete Blockage 1406 1407
Device Alarm System 1401 1401
No Flow 1030 1030
Failure To Adhere Or Bond 1029 1029
Infusion or Flow Problem 965 965
Device Displays Incorrect Message 946 946
Insufficient Flow or Under Infusion 906 906
Restricted Flow rate 893 893
Device Operates Differently Than Expected 859 859
Material Twisted/Bent 840 840
Device Contamination with Chemical or Other Material 821 821
Loss of or Failure to Bond 692 692
Material Deformation 678 678
Failure to Prime 627 627
Free or Unrestricted Flow 596 596
Detachment Of Device Component 572 572
Bent 558 558
Improper Flow or Infusion 517 517
Reflux within Device 507 507
Backflow 500 500
Adverse Event Without Identified Device or Use Problem 483 483
Obstruction of Flow 483 483
Connection Problem 466 466
Material Puncture/Hole 369 369
Occlusion Within Device 320 320
Filling Problem 310 310
Hole In Material 287 287
Excess Flow or Over-Infusion 274 274
Insufficient Information 274 274
Loose or Intermittent Connection 273 273
Mechanical Problem 264 264
Failure to Infuse 235 235
Material Split, Cut or Torn 235 235
Failure to Deliver 217 217
Physical Resistance/Sticking 217 217
Component Missing 214 214
Partial Blockage 196 196
Kinked 196 196
Output Problem 173 173
Protective Measures Problem 164 164
Defective Device 162 162
Contamination /Decontamination Problem 154 154
Device Dislodged or Dislocated 151 151
Tear, Rip or Hole in Device Packaging 148 148
Material Fragmentation 147 147
Audible Prompt/Feedback Problem 139 139
Stretched 138 138
Material Rupture 136 136
Defective Component 136 136
Material Integrity Problem 136 136
Packaging Problem 127 127
Failure to Disconnect 126 126
Inaccurate Delivery 119 119
Air Leak 119 119
Sticking 118 118
Fitting Problem 104 104
Separation Failure 104 104
Activation Problem 102 102
Improper or Incorrect Procedure or Method 100 100
Appropriate Term/Code Not Available 91 91
False Alarm 83 83
Fracture 80 80
Deformation Due to Compressive Stress 78 78
Difficult to Remove 73 73
Air/Gas in Device 73 73
Flushing Problem 64 64
Retraction Problem 63 63
Manufacturing, Packaging or Shipping Problem 62 62
Pressure Problem 59 59
Gas Leak 59 59
Product Quality Problem 58 58
Cut In Material 57 57
Unsealed Device Packaging 56 56
Difficult to Flush 56 56
Device Operational Issue 53 53
Device Damaged Prior to Use 51 51
Failure to Sense 50 50
Use of Device Problem 50 50
Device Slipped 49 49
Volume Accuracy Problem 48 48
No Apparent Adverse Event 46 46
Inaccurate Flow Rate 46 46
Separation Problem 45 45
Chemical Spillage 45 45
Contamination 44 44
Device Markings/Labelling Problem 43 43
Incomplete or Inadequate Connection 41 41
Fail-Safe Did Not Operate 39 39
Delivered as Unsterile Product 38 38
Migration or Expulsion of Device 37 37
Difficult or Delayed Activation 36 36
Material Discolored 34 34
Therapeutic or Diagnostic Output Failure 34 34

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 18767 18776
No Known Impact Or Consequence To Patient 10403 10403
No Clinical Signs, Symptoms or Conditions 6432 6433
Hyperglycemia 4379 4379
No Patient Involvement 3959 3961
No Information 2902 2904
Insufficient Information 1064 1064
Diabetic Ketoacidosis 997 997
Chemical Exposure 510 510
Blood Loss 311 311
Device Embedded In Tissue or Plaque 230 230
Hypoglycemia 190 190
Unspecified Infection 186 186
No Code Available 185 185
Low Blood Pressure/ Hypotension 160 160
Underdose 152 152
Complaint, Ill-Defined 147 147
Needle Stick/Puncture 129 129
Pain 126 126
Inadequate Pain Relief 115 115
Death 96 96
Therapeutic Response, Decreased 93 93
Hemorrhage/Bleeding 74 74
Inflammation 65 65
Dyspnea 63 63
Not Applicable 63 63
Erythema 58 58
Vomiting 54 54
Foreign Body In Patient 52 52
High Blood Pressure/ Hypertension 51 51
Exposure to Body Fluids 51 51
Coma 48 48
Patient Problem/Medical Problem 45 45
Fever 45 45
Nausea 44 44
Bacterial Infection 42 42
Fatigue 40 40
Skin Irritation 39 39
Air Embolism 37 37
Headache 35 35
Cardiac Arrest 32 32
Missed Dose 32 32
Swelling 31 31
Rash 31 31
Venipuncture 29 29
Reaction, Injection Site 29 29
Overdose 27 27
Loss of consciousness 26 26
Injury 26 26
Malaise 26 26
Low Oxygen Saturation 23 23
Chest Tightness/Pressure 22 22
Skin Inflammation 22 22
Discomfort 22 22
Irritation 21 21
Bradycardia 21 21
Local Reaction 19 19
Tissue Damage 18 18
Tachycardia 18 18
Sepsis 17 17
Hypersensitivity/Allergic reaction 17 17
Hepatitis 17 17
Hypoxia 16 16
Respiratory Distress 15 15
Therapeutic Effects, Unexpected 15 15
Diarrhea 15 15
Dizziness 14 14
Infiltration into Tissue 14 14
Extravasation 13 13
Cellulitis 13 13
Abscess 13 13
Reaction 13 13
Anxiety 13 13
Skin Inflammation/ Irritation 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Apnea 12 12
Cardiopulmonary Arrest 11 11
Burning Sensation 11 11
Dehydration 10 10
Lethargy 10 10
Injection Site Reaction 9 9
Skin Discoloration 9 9
Weakness 9 9
Seizures 8 8
Neurological Deficit/Dysfunction 8 8
Chest Pain 8 8
Hemolysis 8 8
Therapeutic Response, Increased 8 8
Test Result 7 7
Shaking/Tremors 7 7
Hematoma 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

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