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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 4
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
  1.  K210217  Needleless Connector
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
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 3591 3591

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 19662 19662
Leak/Splash 13993 13993
Fluid/Blood Leak 12817 12817
Loss of or Failure to Bond 8091 8091
Detachment of Device or Device Component 5316 5316
Infusion or Flow Problem 4539 4539
Device Alarm System 4504 4504
Complete Blockage 3206 3207
Air/Gas in Device 1926 1926
Break 1896 1896
No Apparent Adverse Event 1686 1686
Material Separation 1593 1593
Crack 1436 1436
Disconnection 1338 1338
Insufficient Flow or Under Infusion 1132 1132
Material Deformation 1067 1067
Restricted Flow rate 998 998
No Flow 945 945
Defective Component 942 942
Device Contamination with Chemical or Other Material 859 859
Patient Device Interaction Problem 799 799
Backflow 776 776
Obstruction of Flow 774 774
Device Handling Problem 759 759
Adverse Event Without Identified Device or Use Problem 727 727
Free or Unrestricted Flow 707 707
Connection Problem 689 689
Audible Prompt/Feedback Problem 481 481
Material Puncture/Hole 464 464
Improper Flow or Infusion 456 456
Activation Problem 392 392
Tear, Rip or Hole in Device Packaging 352 352
Inaccurate Delivery 352 352
Material Split, Cut or Torn 341 341
Defective Device 308 308
Product Quality Problem 302 302
Mechanical Problem 288 288
Loose or Intermittent Connection 271 271
Excess Flow or Over-Infusion 266 266
Component Missing 253 253
Failure to Infuse 245 245
Contamination /Decontamination Problem 231 231
Filling Problem 230 230
Contamination 226 226
Failure to Prime 219 219
Separation Problem 213 213
Output Problem 203 203
False Alarm 176 176
Insufficient Information 162 162
Material Integrity Problem 151 151

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58055 58056
Hyperglycemia 16222 16222
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 3869 3869
Insufficient Information 3239 3239
No Patient Involvement 1432 1434
No Information 1136 1137
No Known Impact Or Consequence To Patient 828 828
Chemical Exposure 681 681
Hypoglycemia 607 607
Hemorrhage/Bleeding 546 546
Unspecified Infection 427 427
Pain 369 369
Skin Inflammation/ Irritation 367 367
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 342 342
Erythema 209 209
Low Blood Pressure/ Hypotension 198 198
Needle Stick/Puncture 174 174
Inflammation 92 92
Pulmonary Hypertension 81 81
Hypersensitivity/Allergic reaction 80 80
Itching Sensation 79 79
Unspecified Tissue Injury 77 77
Swelling/ Edema 75 75
Vomiting 74 74
Nausea 74 74
Blood Loss 72 72
Headache 72 72
Local Reaction 69 69
Inadequate Pain Relief 67 67
Exposure to Body Fluids 66 66
Contact Dermatitis 61 61
Dyspnea 59 59
Tissue Breakdown 58 58
Dizziness 54 54
Underdose 50 50
Discomfort 48 48
Air Embolism 42 42
Cardiac Arrest 41 41
Fatigue 41 41
Tachycardia 38 38
Cellulitis 36 36
High Blood Pressure/ Hypertension 34 34
No Code Available 30 30
Skin Disorders 29 29
Fever 28 28
Reaction to Medicinal Component of Device 27 27
Diarrhea 27 27
Foreign Body In Patient 26 26
Abscess 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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