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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
Product CodeFPA
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
410 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM A.S.
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM AS.
  SUBSTANTIALLY EQUIVALENT 3
ASSET MEDIKAL TASARIM SAN TIC AS.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 3
CAREFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI
  SUBSTANTIALLY EQUIVALENT 2
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 EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDSAFETY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
NP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NP MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
POLY MEDICURE LIMITED
  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
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 3
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU WEI DE LI TRADE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 6570 6570
2019 11213 11213
2020 9553 9553
2021 10391 10392
2022 13392 13392
2023 7796 7796

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 16839 16839
Leak/Splash 8355 8355
Detachment of Device or Device Component 4476 4476
Device Alarm System 4122 4122
Complete Blockage 2685 2686
Break 2509 2509
Material Separation 2211 2211
Disconnection 2154 2154
Crack 1593 1593
Insufficient Flow or Under Infusion 1335 1335
Material Twisted/Bent 1273 1273
Infusion or Flow Problem 1059 1059
Restricted Flow rate 1000 1000
Loss of or Failure to Bond 953 953
Obstruction of Flow 897 897
Device Contamination with Chemical or Other Material 896 896
Air/Gas in Device 838 838
No Flow 829 829
Patient Device Interaction Problem 809 809
Connection Problem 785 785
Backflow 765 765
Free or Unrestricted Flow 668 668
Material Deformation 634 634
Improper Flow or Infusion 567 567
Defective Component 549 549
Material Puncture/Hole 547 547
Audible Prompt/Feedback Problem 481 481
Failure to Prime 393 393
Inaccurate Delivery 372 372
Material Split, Cut or Torn 342 342
Filling Problem 327 327
Excess Flow or Over-Infusion 326 326
Mechanical Problem 321 321
Defective Device 319 319
Adverse Event Without Identified Device or Use Problem 304 304
Loose or Intermittent Connection 298 298
Product Quality Problem 287 287
Insufficient Information 280 280
Activation Problem 271 271
Physical Resistance/Sticking 243 243
Component Missing 238 238
Device Displays Incorrect Message 227 227
Contamination /Decontamination Problem 224 224
Output Problem 207 207
Tear, Rip or Hole in Device Packaging 173 173
Reflux within Device 169 169
False Alarm 167 167
Failure to Infuse 160 160
Separation Problem 158 158
Protective Measures Problem 156 156
Failure to Deliver 145 145
Patient-Device Incompatibility 145 145
Contamination 131 131
Failure to Disconnect 123 123
Device Operates Differently Than Expected 121 121
Stretched 118 118
Fitting Problem 116 116
Packaging Problem 113 113
Failure To Adhere Or Bond 107 107
Device Misassembled During Manufacturing /Shipping 106 106
Deformation Due to Compressive Stress 102 102
Material Integrity Problem 100 100
Material Rupture 99 99
Device Dislodged or Dislocated 98 98
Appropriate Term/Code Not Available 96 96
Partial Blockage 95 95
Pressure Problem 94 94
Fracture 89 89
Material Fragmentation 89 89
Volume Accuracy Problem 89 89
Bent 88 88
Difficult to Flush 87 87
Gas/Air Leak 86 86
Incomplete or Inadequate Connection 83 83
Inaccurate Flow Rate 82 82
Difficult to Remove 81 81
Increase in Pressure 77 77
Flushing Problem 76 76
Device Damaged Prior to Use 76 76
Separation Failure 72 72
Priming Problem 72 72
Hole In Material 69 69
Device Markings/Labelling Problem 67 67
Improper or Incorrect Procedure or Method 64 64
Retraction Problem 62 62
Failure to Sense 62 62
Material Discolored 60 60
Device Sensing Problem 60 60
Detachment Of Device Component 55 55
Use of Device Problem 54 54
Device Difficult to Setup or Prepare 47 47
Particulates 45 45
Fail-Safe Did Not Operate 45 45
No Apparent Adverse Event 44 44
Difficult or Delayed Separation 43 43
Delivered as Unsterile Product 41 41
Occlusion Within Device 40 40
Misassembled 40 40
Therapeutic or Diagnostic Output Failure 40 40
Difficult or Delayed Activation 37 37

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25082 25083
No Consequences Or Impact To Patient 14153 14162
No Known Impact Or Consequence To Patient 5451 5451
No Information 2672 2674
No Patient Involvement 2619 2621
Hyperglycemia 2538 2538
Insufficient Information 2438 2438
Diabetic Ketoacidosis 1285 1285
Chemical Exposure 677 677
Pain 284 284
Blood Loss 234 234
Erythema 203 203
Hemorrhage/Bleeding 162 162
Low Blood Pressure/ Hypotension 161 161
Needle Stick/Puncture 161 161
Unspecified Infection 140 140
Skin Inflammation/ Irritation 136 136
Inadequate Pain Relief 123 123
Hypoglycemia 107 107
No Code Available 98 98
Underdose 79 79
Inflammation 79 79
Pulmonary Hypertension 77 77
Unspecified Tissue Injury 76 76
Itching Sensation 75 75
Local Reaction 75 75
Therapeutic Response, Decreased 74 74
Exposure to Body Fluids 71 71
Headache 66 66
Swelling/ Edema 66 66
Dyspnea 61 61
Contact Dermatitis 57 57
Death 56 56
Nausea 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
High Blood Pressure/ Hypertension 52 52
Fatigue 43 43
Discomfort 41 41
Cardiac Arrest 38 38
Foreign Body In Patient 38 38
Vomiting 37 37
Dizziness 36 36
Air Embolism 35 35
Patient Problem/Medical Problem 35 35
Cellulitis 34 34
Rash 33 33
Hypersensitivity/Allergic reaction 30 30
Device Embedded In Tissue or Plaque 30 30
Low Oxygen Saturation 29 29
Skin Disorders 29 29
Diarrhea 29 29
Venipuncture 28 28
Anxiety 27 27
Fever 27 27
Extravasation 26 26
Reaction, Injection Site 26 26
Tachycardia 25 25
Bacterial Infection 24 24
Reaction to Medicinal Component of Device 23 23
Coma 22 22
Swelling 21 21
Skin Irritation 20 20
Sepsis 20 20
Loss of consciousness 20 20
Injection Site Reaction 19 19
Nodule 19 19
Infiltration into Tissue 19 19
Overdose 18 18
Injury 18 18
Hepatitis 17 17
Abscess 16 16
Bruise/Contusion 16 16
Missed Dose 16 16
Skin Inflammation 15 15
Bradycardia 15 15
Skin Discoloration 15 15
Therapeutic Effects, Unexpected 15 15
Tissue Damage 15 15
Complaint, Ill-Defined 15 15
Hematoma 14 14
Hypoxia 14 14
Lethargy 14 14
Tissue Breakdown 13 13
Malaise 13 13
Chest Pain 13 13
Subcutaneous Nodule 12 12
Irritability 11 11
Not Applicable 11 11
Awareness during Anaesthesia 11 11
Apnea 10 10
Exsanguination 10 10
Emotional Changes 10 10
Syncope/Fainting 10 10
Reaction 9 9
Increased Respiratory Rate 9 9
Respiratory Distress 9 9
Neurological Deficit/Dysfunction 8 8
Therapeutic Response, Increased 8 8
Weakness 8 8
Burning Sensation 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Nov-08-2022
2 B. Braun Medical, Inc. II Oct-14-2022
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 Baxter Healthcare Corporation I Sep-14-2022
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 CAREFUSION II Sep-13-2022
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 Codan US Corporation II Jun-26-2020
28 ConMed Corporation II Feb-28-2018
29 ICU Medical, Inc. II Sep-09-2022
30 ICU Medical, Inc. II May-13-2021
31 ICU Medical, Inc. II Dec-23-2020
32 ICU Medical, Inc. II Oct-22-2020
33 ICU Medical, Inc. II May-06-2020
34 ICU Medical, Inc. I Apr-15-2019
35 Medtronic Inc. II Jul-05-2018
36 Molded Products Inc II Aug-22-2019
37 Quest Medical, Inc. II Feb-07-2023
38 Repro-Med Systems, Inc. II Oct-07-2019
39 Repro-Med Systems, Inc. II Jan-05-2018
40 Smiths Medical ASD Inc. I Jan-30-2023
41 Smiths Medical ASD Inc. II Oct-19-2021
42 Smiths Medical ASD Inc. II Oct-24-2019
43 Smiths Medical ASD Inc. II Oct-11-2018
44 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
45 Unomedical A/S II Sep-26-2022
46 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
47 Vygon U.S.A. II Apr-09-2019
48 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
49 Zyno Medical LLC II Jul-23-2019
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