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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
  1.  K220288  NP Medical nPulse K150 Neutral Displacement Needle ...
NP MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220288  NP Medical nPulse K150 Neutral Displacement Needle ...
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 47215 47215
2025 6896 6896

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 21083 21083
Leak/Splash 14420 14420
Fluid/Blood Leak 12990 12990
Loss of or Failure to Bond 8110 8110
Detachment of Device or Device Component 5528 5528
Infusion or Flow Problem 4766 4766
Device Alarm System 4520 4520
Complete Blockage 3247 3248
Air/Gas in Device 2028 2028
Break 1942 1942
No Apparent Adverse Event 1750 1750
Material Separation 1604 1604
Crack 1459 1459
Disconnection 1357 1357
Insufficient Flow or Under Infusion 1137 1137
Material Deformation 1132 1132
Restricted Flow rate 1000 1000
Defective Component 977 977
No Flow 970 970
Adverse Event Without Identified Device or Use Problem 873 873
Device Contamination with Chemical or Other Material 863 863
Device Handling Problem 820 820
Patient Device Interaction Problem 799 799
Obstruction of Flow 783 783
Backflow 780 780
Free or Unrestricted Flow 711 711
Connection Problem 695 695
Audible Prompt/Feedback Problem 481 481
Material Puncture/Hole 466 466
Improper Flow or Infusion 461 461
Activation Problem 399 399
Tear, Rip or Hole in Device Packaging 370 370
Inaccurate Delivery 355 355
Material Split, Cut or Torn 351 351
Defective Device 309 309
Product Quality Problem 304 304
Mechanical Problem 288 288
Loose or Intermittent Connection 272 272
Excess Flow or Over-Infusion 267 267
Component Missing 256 256
Failure to Infuse 255 255
Contamination /Decontamination Problem 247 247
Contamination 239 239
Filling Problem 232 232
Failure to Prime 219 219
Separation Problem 217 217
Output Problem 203 203
False Alarm 176 176
Material Integrity Problem 162 162
Insufficient Information 162 162

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60221 60222
Hyperglycemia 16908 16908
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 4136 4136
Insufficient Information 3262 3262
No Patient Involvement 1432 1434
No Information 1136 1137
No Known Impact Or Consequence To Patient 828 828
Chemical Exposure 683 683
Hypoglycemia 647 647
Hemorrhage/Bleeding 590 590
Unspecified Infection 449 449
Pain 396 396
Skin Inflammation/ Irritation 387 387
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 345 345
Low Blood Pressure/ Hypotension 213 213
Erythema 209 209
Needle Stick/Puncture 176 176
Vomiting 104 104
Inflammation 94 94
Nausea 89 89
Hypersensitivity/Allergic reaction 85 85
Headache 84 84
Pulmonary Hypertension 81 81
Itching Sensation 79 79
Unspecified Tissue Injury 77 77
Swelling/ Edema 76 76
Blood Loss 72 72
Local Reaction 69 69
Inadequate Pain Relief 67 67
Dizziness 66 66
Exposure to Body Fluids 66 66
Contact Dermatitis 61 61
Dyspnea 60 60
Tissue Breakdown 58 58
Underdose 50 50
Discomfort 50 50
Fatigue 45 45
Air Embolism 45 45
Tachycardia 42 42
Cardiac Arrest 42 42
Cellulitis 37 37
High Blood Pressure/ Hypertension 35 35
No Code Available 30 30
Skin Disorders 29 29
Fever 28 28
Diarrhea 27 27
Abscess 27 27
Reaction to Medicinal Component of Device 27 27
Foreign Body In Patient 26 26

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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