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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
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASSET MEDIKAL TASARIM AS.
  SUBSTANTIALLY EQUIVALENT 3
ASSET MEDIKAL TASARIM SAN TIC AS.
  SUBSTANTIALLY EQUIVALENT 1
B.BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CAPILLARY BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARE FUSION
  SUBSTANTIALLY EQUIVALENT 3
CAREFUSION (BD)
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ECOMED SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 SUYUN MEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LILY MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NP MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NP MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLY MEDICURE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PURACATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
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
2021 10414 10554
2022 13394 13647
2023 10916 10949
2024 47210 47213
2025 35089 35089
2026 53278 56250

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 32705 33216
Leak/Splash 20831 21322
Loss of or Failure to Bond 18863 19612
Fluid/Blood Leak 16975 17302
Premature Separation 13861 14676
Adverse Event Without Identified Device or Use Problem 11094 11150
Detachment of Device or Device Component 9721 9893
Infusion or Flow Problem 9143 9150
Complete Blockage 7654 7939
Device Alarm System 4535 4552
Use of Incorrect Control/Treatment Settings 4434 4964
Air/Gas in Device 3007 3023
Device Handling Problem 2863 2911
No Apparent Adverse Event 2431 2431
Break 2348 2361
Crack 1862 1874
Material Deformation 1841 1844
Appropriate Term/Code Not Available 1741 1751
Partial Blockage 1570 1570
Obstruction of Flow 1560 1575
Material Separation 1482 1485
Disconnection 1321 1337
No Flow 1212 1230
Defective Component 1210 1241
Insufficient Flow or Under Infusion 1019 1027
Connection Problem 934 946
Backflow 900 903
Patient Device Interaction Problem 794 794
Loose or Intermittent Connection 772 916
Device Contamination with Chemical or Other Material 761 763
Restricted Flow rate 755 755
Free or Unrestricted Flow 616 618
Tear, Rip or Hole in Device Packaging 568 568
Material Puncture/Hole 558 562
Material Split, Cut or Torn 534 535
Improper or Incorrect Procedure or Method 506 514
Audible Prompt/Feedback Problem 467 467
Activation Problem 465 466
Contamination 463 463
Separation Problem 457 457
Failure to Fire 413 413
Failure to Infuse 408 408
Defective Device 388 409
Improper Flow or Infusion 387 407
Inaccurate Delivery 386 387
Product Quality Problem 377 406
Contamination /Decontamination Problem 377 386
Excess Flow or Over-Infusion 353 353
Component Missing 282 284
Deformation Due to Compressive Stress 273 275

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109633 111712
Hyperglycemia 37037 38186
Diabetic Ketoacidosis 9543 9624
Insufficient Information 3635 3710
Hypoglycemia 2895 2895
Hemorrhage/Bleeding 1314 1326
No Consequences Or Impact To Patient 892 892
Pain 829 831
Skin Inflammation/ Irritation 818 820
Unspecified Infection 806 813
Skin Infection 650 658
Chemical Exposure 559 560
Vomiting 540 540
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 393 396
Headache 389 393
Nausea 388 396
Erythema 281 281
Low Blood Pressure/ Hypotension 265 265
Fatigue 250 250
Needle Stick/Puncture 206 206
Cellulitis 196 196
Abscess 191 191
Dizziness 190 190
Swelling/ Edema 171 173
Polydipsia 142 142
Confusion/ Disorientation 135 135
Inflammation 117 117
Hypersensitivity/Allergic reaction 116 117
Itching Sensation 114 114
Exposure to Body Fluids 114 114
Malaise 105 105
Abdominal Pain 102 102
Discomfort 100 100
No Information 98 98
Loss of consciousness 92 92
Nodule 92 92
No Patient Involvement 89 89
Local Reaction 83 83
Pulmonary Hypertension 82 82
Unspecified Tissue Injury 79 79
Dyspnea 78 78
Tissue Breakdown 71 71
Contact Dermatitis 65 65
Urinary Frequency 63 63
Shaking/Tremors 63 63
Distress 62 62
Dry Mouth 60 60
High Blood Pressure/ Hypertension 60 63
Dyskinesia 59 59
Anxiety 58 58

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 Nov-26-2025
4 B. Braun Medical, Inc. II Sep-13-2024
5 B. Braun Medical, Inc. II Jul-17-2024
6 B. Braun Medical, Inc. I Dec-01-2023
7 B. Braun Medical, Inc. II Nov-03-2023
8 B. Braun Medical, Inc. II Oct-14-2022
9 B. Braun Medical, Inc. II Sep-24-2021
10 B. Braun Medical, Inc. II Jul-23-2021
11 B. Braun Medical, Inc. II Apr-29-2021
12 BD SWITZERLAND SARL II Jun-12-2025
13 BD SWITZERLAND SARL II May-31-2024
14 Baxter Healthcare Corporation II Sep-19-2025
15 Baxter Healthcare Corporation II Jan-22-2025
16 Baxter Healthcare Corporation II Mar-14-2024
17 Baxter Healthcare Corporation I Sep-14-2022
18 Baxter Healthcare Corporation II Feb-09-2021
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 CareFusion 303, Inc. I Oct-08-2025
24 Fresenius Kabi USA, LLC I Jun-06-2025
25 Fresenius Kabi USA, LLC I Sep-04-2024
26 ICU Medical Inc. II Sep-04-2025
27 ICU Medical, Inc. II Jan-16-2026
28 ICU Medical, Inc. II Sep-09-2022
29 ICU Medical, Inc. II May-13-2021
30 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
31 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
32 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
33 Medline Industries, LP II Feb-13-2026
34 Molded Products Inc II Apr-06-2026
35 Quest Medical, Inc. II Oct-28-2023
36 Quest Medical, Inc. II Feb-07-2023
37 Smiths Medical ASD Inc. II Oct-18-2024
38 Smiths Medical ASD Inc. I Jan-30-2023
39 Smiths Medical ASD Inc. II Oct-19-2021
40 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
41 Unomedical A/S II Sep-19-2024
42 Unomedical A/S II Apr-15-2024
43 Unomedical A/S I Nov-21-2023
44 Unomedical A/S II Sep-26-2022
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