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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 3
ASSET MEDIKAL TASARIM SAN TIC AS.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
BQ PLUS MEDICAL CO., LTD
  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
ECOMED SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI
  SUBSTANTIALLY EQUIVALENT 2
INNOVATIVE HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
  1.  K202437  Infusion Sets for Single Use
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LILY MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
Q FOR PLASTIC INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  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 2
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
2019 11213 11213
2020 9553 9553
2021 10393 10394
2022 13395 13395
2023 10920 10920
2024 47215 47215
2025 6896 6896

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 21576 21576
Fluid/Blood Leak 17498 17498
Leak/Splash 15097 15097
Loss of or Failure to Bond 8285 8285
Detachment of Device or Device Component 7068 7068
Infusion or Flow Problem 4929 4929
Device Alarm System 4603 4603
Complete Blockage 3295 3296
Break 2563 2563
Material Separation 2157 2157
Disconnection 2109 2109
Air/Gas in Device 2028 2028
Crack 1828 1828
No Apparent Adverse Event 1755 1755
Insufficient Flow or Under Infusion 1404 1404
Material Deformation 1340 1340
No Flow 1145 1145
Obstruction of Flow 1019 1019
Restricted Flow rate 1009 1009
Defective Component 991 991
Device Contamination with Chemical or Other Material 985 985
Backflow 938 938
Adverse Event Without Identified Device or Use Problem 937 937
Device Handling Problem 834 834
Patient Device Interaction Problem 809 809
Connection Problem 796 796
Free or Unrestricted Flow 758 758
Material Puncture/Hole 626 626
Improper Flow or Infusion 595 595
Audible Prompt/Feedback Problem 481 481
Material Split, Cut or Torn 433 433
Activation Problem 426 426
Inaccurate Delivery 400 400
Tear, Rip or Hole in Device Packaging 396 396
Excess Flow or Over-Infusion 355 355
Loose or Intermittent Connection 328 328
Failure to Prime 327 327
Defective Device 325 325
Mechanical Problem 321 321
Filling Problem 315 315
Product Quality Problem 309 309
Component Missing 300 300
Contamination /Decontamination Problem 300 300
Failure to Infuse 278 278
Insufficient Information 270 270
Contamination 251 251
Physical Resistance/Sticking 240 240
Separation Problem 231 231
Output Problem 207 207
Material Integrity Problem 194 194

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60229 60230
Hyperglycemia 17456 17456
No Consequences Or Impact To Patient 10897 10906
Diabetic Ketoacidosis 4700 4700
No Known Impact Or Consequence To Patient 3667 3667
Insufficient Information 3262 3262
No Information 2500 2502
No Patient Involvement 2247 2249
Chemical Exposure 812 812
Hypoglycemia 668 668
Hemorrhage/Bleeding 597 597
Unspecified Infection 477 477
Pain 428 428
Skin Inflammation/ Irritation 387 387
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 345 345
Low Blood Pressure/ Hypotension 236 236
Erythema 211 211
Needle Stick/Puncture 206 206
Blood Loss 162 162
Vomiting 105 105
Headache 97 97
Inflammation 97 97
Nausea 94 94
Inadequate Pain Relief 88 88
Hypersensitivity/Allergic reaction 86 86
Pulmonary Hypertension 81 81
Exposure to Body Fluids 80 80
Itching Sensation 79 79
Unspecified Tissue Injury 77 77
Swelling/ Edema 76 76
Local Reaction 71 71
Dyspnea 68 68
Underdose 67 67
Dizziness 67 67
No Code Available 62 62
Contact Dermatitis 61 61
Tissue Breakdown 58 58
Discomfort 54 54
Fatigue 50 50
High Blood Pressure/ Hypertension 48 48
Air Embolism 45 45
Cardiac Arrest 44 44
Tachycardia 44 44
Therapeutic Response, Decreased 43 43
Cellulitis 40 40
Death 33 33
Fever 33 33
Foreign Body In Patient 31 31
Diarrhea 31 31
Low Oxygen Saturation 30 30

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Nov-08-2022
2 B. Braun Medical, Inc. II Sep-13-2024
3 B. Braun Medical, Inc. II Jul-17-2024
4 B. Braun Medical, Inc. I Dec-01-2023
5 B. Braun Medical, Inc. II Nov-03-2023
6 B. Braun Medical, Inc. II Oct-14-2022
7 B. Braun Medical, Inc. II Sep-24-2021
8 B. Braun Medical, Inc. II Jul-23-2021
9 B. Braun Medical, Inc. II Apr-29-2021
10 B. Braun Medical, Inc. II Feb-02-2020
11 B. Braun Medical, Inc. I Sep-23-2019
12 BD SWITZERLAND SARL II May-31-2024
13 BD SWITZERLAND SARL II May-13-2020
14 Baxter Healthcare Corporation II Jan-22-2025
15 Baxter Healthcare Corporation II Mar-14-2024
16 Baxter Healthcare Corporation I Sep-14-2022
17 Baxter Healthcare Corporation II Feb-09-2021
18 Baxter Healthcare Corporation II Jan-09-2020
19 Becton Dickinson & Company II Nov-17-2023
20 Becton Dickinson & Company II Nov-04-2019
21 Becton Dickinson & Company II Oct-07-2019
22 Becton Dickinson & Company I Jul-11-2019
23 Becton Dickinson & Company I Jun-26-2019
24 Becton Dickinson & Company II Apr-10-2019
25 CAREFUSION II Sep-13-2022
26 CAREFUSION II Sep-13-2021
27 CAREFUSION II Jul-01-2021
28 CME America, LLC I Jul-15-2020
29 CME America, LLC II May-04-2020
30 Codan US Corporation II Jun-26-2020
31 Fresenius Kabi USA, LLC I Sep-04-2024
32 ICU Medical, Inc. II Sep-09-2022
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 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
39 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
40 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
41 Molded Products Inc II Aug-22-2019
42 Quest Medical, Inc. II Oct-28-2023
43 Quest Medical, Inc. II Feb-07-2023
44 Repro-Med Systems, Inc. II Oct-07-2019
45 Smiths Medical ASD Inc. II Oct-18-2024
46 Smiths Medical ASD Inc. I Jan-30-2023
47 Smiths Medical ASD Inc. II Oct-19-2021
48 Smiths Medical ASD Inc. II Oct-24-2019
49 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
50 Unomedical A/S II Sep-19-2024
51 Unomedical A/S II Apr-15-2024
52 Unomedical A/S I Nov-21-2023
53 Unomedical A/S II Sep-26-2022
54 Vygon U.S.A. II Apr-09-2019
55 Zyno Medical LLC II Jul-23-2019
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