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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 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 (BD)
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ECOMED SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
TANDEM DIABETES CARE
  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 9563 9643
2021 10414 10543
2022 13394 13626
2023 10916 10927
2024 47209 47209
2025 30742 30742

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 25660 25691
Leak/Splash 18038 18071
Fluid/Blood Leak 14903 15002
Loss of or Failure to Bond 8347 8347
Detachment of Device or Device Component 7738 7759
Infusion or Flow Problem 7642 7649
Device Alarm System 4659 4668
Complete Blockage 3735 3736
Adverse Event Without Identified Device or Use Problem 2947 2950
Air/Gas in Device 2693 2708
Break 2443 2459
No Apparent Adverse Event 2198 2198
Crack 1859 1868
Material Separation 1803 1803
Material Deformation 1770 1773
Disconnection 1566 1583
Device Handling Problem 1524 1524
No Flow 1259 1276
Defective Component 1242 1276
Insufficient Flow or Under Infusion 1228 1230
Obstruction of Flow 1080 1093
Restricted Flow rate 1006 1006
Backflow 936 939
Device Contamination with Chemical or Other Material 910 911
Connection Problem 826 837
Patient Device Interaction Problem 801 801
Free or Unrestricted Flow 775 777
Material Puncture/Hole 556 561
Improper Flow or Infusion 529 549
Tear, Rip or Hole in Device Packaging 504 504
Material Split, Cut or Torn 498 505
Audible Prompt/Feedback Problem 481 481
Activation Problem 446 446
Defective Device 383 416
Contamination /Decontamination Problem 379 394
Contamination 368 368
Failure to Infuse 364 364
Inaccurate Delivery 363 363
Excess Flow or Over-Infusion 340 343
Product Quality Problem 338 366
Separation Problem 322 322
Loose or Intermittent Connection 317 319
Component Missing 304 305
Mechanical Problem 300 302
Improper or Incorrect Procedure or Method 269 271
Filling Problem 246 247
Failure to Prime 237 244
Packaging Problem 215 215
Material Integrity Problem 213 213
Output Problem 204 209

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76388 76602
Hyperglycemia 19985 20038
Diabetic Ketoacidosis 7161 7173
No Consequences Or Impact To Patient 6025 6034
Insufficient Information 3511 3600
No Patient Involvement 1432 1436
Hypoglycemia 1262 1262
No Information 1136 1137
No Known Impact Or Consequence To Patient 832 870
Hemorrhage/Bleeding 797 797
Chemical Exposure 723 724
Unspecified Infection 604 611
Pain 535 537
Skin Inflammation/ Irritation 469 469
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 372 375
Vomiting 307 307
Low Blood Pressure/ Hypotension 267 267
Erythema 215 215
Headache 211 215
Needle Stick/Puncture 193 193
Nausea 191 199
Fatigue 124 124
Dizziness 114 114
Hypersensitivity/Allergic reaction 108 109
Inflammation 100 100
Swelling/ Edema 97 99
Itching Sensation 83 83
Pulmonary Hypertension 82 82
Unspecified Tissue Injury 79 79
Exposure to Body Fluids 78 78
Dyspnea 77 79
Blood Loss 72 72
Local Reaction 69 69
Inadequate Pain Relief 68 68
Tissue Breakdown 63 63
High Blood Pressure/ Hypertension 63 66
Contact Dermatitis 62 62
Discomfort 61 61
Confusion/ Disorientation 56 56
Underdose 50 50
Tachycardia 50 50
Air Embolism 50 51
Cardiac Arrest 48 50
Skin Infection 46 46
Distress 45 45
Cellulitis 39 39
Loss of consciousness 39 39
Diarrhea 34 35
Anxiety 34 34
Fever 34 35

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