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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 6
BQ PLUS MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAPILLARY BIOMEDICAL, LLC.
  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
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
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
PFM 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
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 1
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU WEI DE LI TRADE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 9553 9553
2021 10393 10394
2022 13395 13395
2023 10920 10920
2024 47214 47214
2025 20912 20912

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 25019 25019
Leak/Splash 16355 16355
Fluid/Blood Leak 13842 13842
Loss of or Failure to Bond 8266 8266
Detachment of Device or Device Component 6608 6608
Infusion or Flow Problem 6237 6237
Device Alarm System 4615 4615
Complete Blockage 3505 3506
Air/Gas in Device 2453 2453
Break 2227 2227
Adverse Event Without Identified Device or Use Problem 2067 2067
No Apparent Adverse Event 2033 2033
Material Separation 1700 1700
Crack 1669 1669
Material Deformation 1472 1472
Disconnection 1446 1446
Device Handling Problem 1188 1188
Insufficient Flow or Under Infusion 1188 1188
No Flow 1156 1156
Defective Component 1114 1114
Restricted Flow rate 1004 1004
Obstruction of Flow 918 918
Device Contamination with Chemical or Other Material 891 891
Backflow 861 861
Patient Device Interaction Problem 801 801
Free or Unrestricted Flow 762 762
Connection Problem 730 730
Improper Flow or Infusion 502 502
Material Puncture/Hole 496 496
Audible Prompt/Feedback Problem 481 481
Material Split, Cut or Torn 441 441
Activation Problem 422 422
Tear, Rip or Hole in Device Packaging 414 414
Inaccurate Delivery 363 363
Defective Device 353 353
Product Quality Problem 328 328
Contamination /Decontamination Problem 326 326
Failure to Infuse 317 317
Contamination 314 314
Mechanical Problem 295 295
Excess Flow or Over-Infusion 294 294
Loose or Intermittent Connection 289 289
Component Missing 279 279
Separation Problem 252 252
Filling Problem 241 241
Failure to Prime 231 231
Output Problem 203 203
Material Integrity Problem 200 200
Packaging Problem 193 193
Improper or Incorrect Procedure or Method 192 192

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69542 69543
Hyperglycemia 19226 19226
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 5719 5719
Insufficient Information 3360 3360
No Patient Involvement 1432 1434
No Information 1136 1137
Hypoglycemia 966 966
No Known Impact Or Consequence To Patient 828 828
Hemorrhage/Bleeding 709 709
Chemical Exposure 701 701
Unspecified Infection 532 532
Pain 469 469
Skin Inflammation/ Irritation 423 423
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 363 363
Low Blood Pressure/ Hypotension 240 240
Erythema 211 211
Vomiting 189 189
Needle Stick/Puncture 189 189
Headache 141 141
Nausea 126 126
Hypersensitivity/Allergic reaction 102 102
Inflammation 97 97
Dizziness 89 89
Swelling/ Edema 88 88
Pulmonary Hypertension 82 82
Itching Sensation 80 80
Unspecified Tissue Injury 79 79
Blood Loss 72 72
Exposure to Body Fluids 71 71
Local Reaction 69 69
Dyspnea 68 68
Inadequate Pain Relief 67 67
Tissue Breakdown 62 62
Contact Dermatitis 62 62
Fatigue 58 58
High Blood Pressure/ Hypertension 57 57
Discomfort 52 52
Underdose 50 50
Tachycardia 49 49
Air Embolism 45 45
Cardiac Arrest 44 44
Cellulitis 39 39
Confusion/ Disorientation 38 38
Diarrhea 31 31
Loss of consciousness 31 31
No Code Available 30 30
Low Oxygen Saturation 30 30
Distress 30 30
Abscess 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 BD SWITZERLAND SARL II Jun-12-2025
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 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 Codan US Corporation II Jun-26-2020
26 Fresenius Kabi USA, LLC I Jun-06-2025
27 Fresenius Kabi USA, LLC I Sep-04-2024
28 ICU Medical, Inc. II Sep-09-2022
29 ICU Medical, Inc. II May-13-2021
30 ICU Medical, Inc. II Dec-23-2020
31 ICU Medical, Inc. II Oct-22-2020
32 ICU Medical, Inc. II May-06-2020
33 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
34 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
35 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
36 Quest Medical, Inc. II Oct-28-2023
37 Quest Medical, Inc. II Feb-07-2023
38 Smiths Medical ASD Inc. II Oct-18-2024
39 Smiths Medical ASD Inc. I Jan-30-2023
40 Smiths Medical ASD Inc. II Oct-19-2021
41 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
42 Unomedical A/S II Sep-19-2024
43 Unomedical A/S II Apr-15-2024
44 Unomedical A/S I Nov-21-2023
45 Unomedical A/S II Sep-26-2022
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