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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
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
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 47216 47216

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 18029 18029
Leak/Splash 13670 13670
Fluid/Blood Leak 12588 12588
Loss of or Failure to Bond 8083 8083
Detachment of Device or Device Component 5095 5095
Device Alarm System 4501 4501
Infusion or Flow Problem 4209 4209
Complete Blockage 3150 3151
Break 1873 1873
Air/Gas in Device 1851 1851
No Apparent Adverse Event 1648 1648
Material Separation 1573 1573
Crack 1396 1396
Disconnection 1321 1321
Insufficient Flow or Under Infusion 1129 1129
Restricted Flow rate 998 998
Material Deformation 998 998
Defective Component 918 918
No Flow 913 913
Device Contamination with Chemical or Other Material 852 852
Patient Device Interaction Problem 799 799
Backflow 763 763
Obstruction of Flow 761 761
Free or Unrestricted Flow 703 703
Connection Problem 684 684
Device Handling Problem 671 671
Adverse Event Without Identified Device or Use Problem 568 568
Audible Prompt/Feedback Problem 481 481
Material Puncture/Hole 457 457
Improper Flow or Infusion 454 454
Activation Problem 383 383
Inaccurate Delivery 351 351
Material Split, Cut or Torn 332 332
Tear, Rip or Hole in Device Packaging 322 322
Defective Device 305 305
Product Quality Problem 298 298
Mechanical Problem 288 288
Loose or Intermittent Connection 265 265
Excess Flow or Over-Infusion 262 262
Component Missing 245 245
Failure to Infuse 234 234
Filling Problem 227 227
Failure to Prime 219 219
Contamination /Decontamination Problem 219 219
Contamination 210 210
Separation Problem 206 206
Output Problem 202 202
False Alarm 169 169
Insufficient Information 162 162
Protective Measures Problem 145 145

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55616 55617
Hyperglycemia 15526 15526
No Consequences Or Impact To Patient 6025 6033
Diabetic Ketoacidosis 3567 3567
Insufficient Information 3221 3221
No Patient Involvement 1432 1434
No Information 1136 1137
No Known Impact Or Consequence To Patient 828 828
Chemical Exposure 678 678
Hypoglycemia 551 551
Hemorrhage/Bleeding 515 515
Unspecified Infection 408 408
Skin Inflammation/ Irritation 357 357
Pain 350 350
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 340 340
Erythema 209 209
Low Blood Pressure/ Hypotension 192 192
Needle Stick/Puncture 167 167
Inflammation 92 92
Pulmonary Hypertension 81 81
Hypersensitivity/Allergic reaction 79 79
Itching Sensation 79 79
Unspecified Tissue Injury 77 77
Swelling/ Edema 75 75
Blood Loss 72 72
Local Reaction 69 69
Headache 67 67
Inadequate Pain Relief 67 67
Exposure to Body Fluids 66 66
Nausea 65 65
Vomiting 64 64
Contact Dermatitis 61 61
Dyspnea 59 59
Tissue Breakdown 55 55
Underdose 50 50
Dizziness 49 49
Discomfort 46 46
Air Embolism 41 41
Cardiac Arrest 41 41
Tachycardia 38 38
Fatigue 35 35
Cellulitis 35 35
High Blood Pressure/ Hypertension 34 34
No Code Available 30 30
Skin Disorders 29 29
Fever 28 28
Diarrhea 27 27
Reaction to Medicinal Component of Device 27 27
Abscess 26 26
Foreign Body In Patient 25 25

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