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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 47213 47213
2025 18273 18273

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 24890 24890
Leak/Splash 15897 15897
Fluid/Blood Leak 13601 13601
Loss of or Failure to Bond 8243 8243
Detachment of Device or Device Component 6347 6347
Infusion or Flow Problem 5883 5883
Device Alarm System 4564 4564
Complete Blockage 3437 3438
Air/Gas in Device 2326 2326
Break 2159 2159
No Apparent Adverse Event 1967 1967
Adverse Event Without Identified Device or Use Problem 1787 1787
Material Separation 1674 1674
Crack 1614 1614
Disconnection 1402 1402
Material Deformation 1398 1398
Insufficient Flow or Under Infusion 1174 1174
Device Handling Problem 1105 1105
No Flow 1101 1101
Defective Component 1084 1084
Restricted Flow rate 1001 1001
Device Contamination with Chemical or Other Material 882 882
Obstruction of Flow 877 877
Backflow 835 835
Patient Device Interaction Problem 800 800
Free or Unrestricted Flow 750 750
Connection Problem 714 714
Material Puncture/Hole 488 488
Improper Flow or Infusion 482 482
Audible Prompt/Feedback Problem 481 481
Activation Problem 414 414
Material Split, Cut or Torn 412 412
Tear, Rip or Hole in Device Packaging 401 401
Inaccurate Delivery 361 361
Defective Device 339 339
Product Quality Problem 325 325
Failure to Infuse 306 306
Contamination 304 304
Mechanical Problem 292 292
Contamination /Decontamination Problem 288 288
Excess Flow or Over-Infusion 286 286
Loose or Intermittent Connection 283 283
Component Missing 273 273
Separation Problem 242 242
Filling Problem 238 238
Failure to Prime 225 225
Output Problem 203 203
Material Integrity Problem 190 190
Packaging Problem 186 186
Improper or Incorrect Procedure or Method 181 181

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67696 67697
Hyperglycemia 19021 19021
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 5353 5353
Insufficient Information 3327 3327
No Patient Involvement 1432 1434
No Information 1136 1137
Hypoglycemia 887 887
No Known Impact Or Consequence To Patient 828 828
Chemical Exposure 696 696
Hemorrhage/Bleeding 686 686
Unspecified Infection 502 502
Pain 465 465
Skin Inflammation/ Irritation 420 420
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 363 363
Low Blood Pressure/ Hypotension 230 230
Erythema 211 211
Vomiting 189 189
Needle Stick/Puncture 186 186
Headache 141 141
Nausea 126 126
Hypersensitivity/Allergic reaction 100 100
Inflammation 97 97
Dizziness 87 87
Swelling/ Edema 85 85
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
Inadequate Pain Relief 67 67
Dyspnea 67 67
Contact Dermatitis 62 62
Tissue Breakdown 61 61
Fatigue 58 58
High Blood Pressure/ Hypertension 56 56
Discomfort 52 52
Underdose 50 50
Tachycardia 49 49
Air Embolism 45 45
Cardiac Arrest 44 44
Confusion/ Disorientation 38 38
Cellulitis 38 38
Loss of consciousness 31 31
Diarrhea 31 31
No Code Available 30 30
Low Oxygen Saturation 29 29
Skin Disorders 29 29
Fever 28 28

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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