Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 5
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
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
KAWASUMI LABORATORIES, INC.
  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 3
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
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 2
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU WEI DE LI TRADE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11213 11213
2020 9553 9553
2021 10393 10394
2022 13395 13395
2023 10920 10920
2024 35265 35265

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 16476 16476
Material Twisted/Bent 13364 13364
Leak/Splash 12992 12992
Loss of or Failure to Bond 8235 8235
Detachment of Device or Device Component 5747 5747
Device Alarm System 4531 4531
Infusion or Flow Problem 3330 3330
Complete Blockage 3087 3088
Break 2376 2376
Material Separation 2037 2037
Disconnection 2023 2023
Crack 1654 1654
Air/Gas in Device 1644 1644
Insufficient Flow or Under Infusion 1370 1370
No Apparent Adverse Event 1246 1246
No Flow 1030 1030
Restricted Flow rate 1007 1007
Obstruction of Flow 968 968
Device Contamination with Chemical or Other Material 937 937
Material Deformation 919 919
Backflow 894 894
Defective Component 870 870
Patient Device Interaction Problem 809 809
Connection Problem 769 769
Free or Unrestricted Flow 730 730
Material Puncture/Hole 580 580
Improper Flow or Infusion 574 574
Audible Prompt/Feedback Problem 481 481
Device Handling Problem 413 413
Inaccurate Delivery 393 393
Activation Problem 391 391
Material Split, Cut or Torn 386 386
Excess Flow or Over-Infusion 326 326
Failure to Prime 322 322
Mechanical Problem 320 320
Defective Device 312 312
Filling Problem 306 306
Loose or Intermittent Connection 305 305
Product Quality Problem 292 292
Tear, Rip or Hole in Device Packaging 285 285
Component Missing 276 276
Adverse Event Without Identified Device or Use Problem 273 273
Insufficient Information 262 262
Contamination /Decontamination Problem 247 247
Physical Resistance/Sticking 234 234
Failure to Infuse 215 215
Output Problem 206 206
Separation Problem 197 197
Contamination 189 189
False Alarm 182 182

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47742 47743
Hyperglycemia 13632 13632
No Consequences Or Impact To Patient 10897 10906
No Known Impact Or Consequence To Patient 3667 3667
Diabetic Ketoacidosis 3186 3186
Insufficient Information 3140 3140
No Information 2500 2502
No Patient Involvement 2247 2249
Chemical Exposure 768 768
Hemorrhage/Bleeding 438 438
Hypoglycemia 431 431
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 335 335
Pain 334 334
Skin Inflammation/ Irritation 286 286
Unspecified Infection 284 284
Erythema 211 211
Low Blood Pressure/ Hypotension 194 194
Needle Stick/Puncture 190 190
Blood Loss 162 162
Inflammation 88 88
Inadequate Pain Relief 84 84
Pulmonary Hypertension 78 78
Unspecified Tissue Injury 77 77
Itching Sensation 77 77
Exposure to Body Fluids 75 75
Headache 72 72
Local Reaction 71 71
Hypersensitivity/Allergic reaction 71 71
Swelling/ Edema 70 70
Underdose 67 67
No Code Available 62 62
Nausea 60 60
Dyspnea 59 59
Contact Dermatitis 58 58
Tissue Breakdown 49 49
Vomiting 49 49
Discomfort 45 45
High Blood Pressure/ Hypertension 44 44
Therapeutic Response, Decreased 43 43
Dizziness 43 43
Cardiac Arrest 43 43
Fatigue 40 40
Cellulitis 35 35
Death 33 33
Tachycardia 31 31
Air Embolism 31 31
Foreign Body In Patient 30 30
Low Oxygen Saturation 29 29
Diarrhea 29 29
Skin Disorders 29 29

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 B. Braun Medical, Inc. I Sep-23-2019
12 BD SWITZERLAND SARL II May-31-2024
13 BD SWITZERLAND SARL II May-13-2020
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 Becton Dickinson & Company II Nov-04-2019
20 Becton Dickinson & Company II Oct-07-2019
21 Becton Dickinson & Company I Jul-11-2019
22 Becton Dickinson & Company I Jun-26-2019
23 Becton Dickinson & Company II Apr-10-2019
24 CAREFUSION II Sep-13-2022
25 CAREFUSION II Sep-13-2021
26 CAREFUSION II Jul-01-2021
27 CME America, LLC I Jul-15-2020
28 CME America, LLC II May-04-2020
29 Codan US Corporation II Jun-26-2020
30 Fresenius Kabi USA, LLC I Sep-04-2024
31 ICU Medical, Inc. II Sep-09-2022
32 ICU Medical, Inc. II May-13-2021
33 ICU Medical, Inc. II Dec-23-2020
34 ICU Medical, Inc. II Oct-22-2020
35 ICU Medical, Inc. II May-06-2020
36 ICU Medical, Inc. I Apr-15-2019
37 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
38 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
39 Molded Products Inc II Aug-22-2019
40 Quest Medical, Inc. II Oct-28-2023
41 Quest Medical, Inc. II Feb-07-2023
42 Repro-Med Systems, Inc. II Oct-07-2019
43 Smiths Medical ASD Inc. I Jan-30-2023
44 Smiths Medical ASD Inc. II Oct-19-2021
45 Smiths Medical ASD Inc. II Oct-24-2019
46 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
47 Unomedical A/S II Sep-19-2024
48 Unomedical A/S II Apr-15-2024
49 Unomedical A/S I Nov-21-2023
50 Unomedical A/S II Sep-26-2022
51 Vygon U.S.A. II Apr-09-2019
52 Zyno Medical LLC II Jul-23-2019
-
-