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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
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
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 14455 14455

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 24019 24019
Leak/Splash 15351 15351
Fluid/Blood Leak 13359 13359
Loss of or Failure to Bond 8197 8197
Detachment of Device or Device Component 5996 5996
Infusion or Flow Problem 5407 5407
Device Alarm System 4548 4548
Complete Blockage 3358 3359
Air/Gas in Device 2243 2243
Break 2083 2083
No Apparent Adverse Event 1872 1872
Material Separation 1648 1648
Crack 1558 1558
Adverse Event Without Identified Device or Use Problem 1397 1397
Disconnection 1387 1387
Material Deformation 1301 1301
Insufficient Flow or Under Infusion 1162 1162
Defective Component 1054 1054
No Flow 1050 1050
Restricted Flow rate 1001 1001
Device Handling Problem 970 970
Device Contamination with Chemical or Other Material 875 875
Obstruction of Flow 825 825
Backflow 820 820
Patient Device Interaction Problem 800 800
Free or Unrestricted Flow 739 739
Connection Problem 700 700
Audible Prompt/Feedback Problem 481 481
Material Puncture/Hole 479 479
Improper Flow or Infusion 476 476
Activation Problem 411 411
Tear, Rip or Hole in Device Packaging 392 392
Material Split, Cut or Torn 386 386
Inaccurate Delivery 361 361
Defective Device 319 319
Product Quality Problem 311 311
Failure to Infuse 295 295
Mechanical Problem 290 290
Contamination 288 288
Excess Flow or Over-Infusion 279 279
Loose or Intermittent Connection 276 276
Contamination /Decontamination Problem 269 269
Component Missing 267 267
Filling Problem 237 237
Separation Problem 233 233
Failure to Prime 223 223
Output Problem 203 203
False Alarm 176 176
Material Integrity Problem 176 176
Packaging Problem 165 165

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65332 65333
Hyperglycemia 18329 18329
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 4813 4813
Insufficient Information 3295 3295
No Patient Involvement 1432 1434
No Information 1136 1137
No Known Impact Or Consequence To Patient 828 828
Hypoglycemia 777 777
Chemical Exposure 687 687
Hemorrhage/Bleeding 644 644
Unspecified Infection 490 490
Pain 451 451
Skin Inflammation/ Irritation 415 415
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 355 355
Low Blood Pressure/ Hypotension 227 227
Erythema 211 211
Needle Stick/Puncture 182 182
Vomiting 150 150
Headache 124 124
Nausea 110 110
Inflammation 97 97
Hypersensitivity/Allergic reaction 95 95
Pulmonary Hypertension 82 82
Dizziness 81 81
Itching Sensation 80 80
Swelling/ Edema 79 79
Unspecified Tissue Injury 79 79
Blood Loss 72 72
Exposure to Body Fluids 70 70
Local Reaction 69 69
Inadequate Pain Relief 67 67
Contact Dermatitis 62 62
Dyspnea 62 62
Tissue Breakdown 58 58
Fatigue 56 56
Underdose 50 50
Discomfort 50 50
High Blood Pressure/ Hypertension 47 47
Tachycardia 47 47
Air Embolism 45 45
Cardiac Arrest 44 44
Cellulitis 38 38
No Code Available 30 30
Confusion/ Disorientation 30 30
Skin Disorders 29 29
Low Oxygen Saturation 29 29
Diarrhea 29 29
Fever 28 28
Abscess 27 27

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 May-31-2024
12 BD SWITZERLAND SARL II May-13-2020
13 Baxter Healthcare Corporation II Jan-22-2025
14 Baxter Healthcare Corporation II Mar-14-2024
15 Baxter Healthcare Corporation I Sep-14-2022
16 Baxter Healthcare Corporation II Feb-09-2021
17 Baxter Healthcare Corporation II Jan-09-2020
18 Becton Dickinson & Company II Nov-17-2023
19 CAREFUSION II Sep-13-2022
20 CAREFUSION II Sep-13-2021
21 CAREFUSION II Jul-01-2021
22 CME America, LLC I Jul-15-2020
23 CME America, LLC II May-04-2020
24 Codan US Corporation II Jun-26-2020
25 Fresenius Kabi USA, LLC I Sep-04-2024
26 ICU Medical, Inc. II Sep-09-2022
27 ICU Medical, Inc. II May-13-2021
28 ICU Medical, Inc. II Dec-23-2020
29 ICU Medical, Inc. II Oct-22-2020
30 ICU Medical, Inc. II May-06-2020
31 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
32 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
33 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
34 Quest Medical, Inc. II Oct-28-2023
35 Quest Medical, Inc. II Feb-07-2023
36 Smiths Medical ASD Inc. II Oct-18-2024
37 Smiths Medical ASD Inc. I Jan-30-2023
38 Smiths Medical ASD Inc. II Oct-19-2021
39 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
40 Unomedical A/S II Sep-19-2024
41 Unomedical A/S II Apr-15-2024
42 Unomedical A/S I Nov-21-2023
43 Unomedical A/S II Sep-26-2022
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