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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 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 4
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 47214 47214
2025 3591 3591

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 20155 20155
Fluid/Blood Leak 17325 17325
Leak/Splash 14670 14670
Loss of or Failure to Bond 8266 8266
Detachment of Device or Device Component 6856 6856
Infusion or Flow Problem 4702 4702
Device Alarm System 4587 4587
Complete Blockage 3254 3255
Break 2517 2517
Material Separation 2146 2146
Disconnection 2090 2090
Air/Gas in Device 1926 1926
Crack 1805 1805
No Apparent Adverse Event 1691 1691
Insufficient Flow or Under Infusion 1399 1399
Material Deformation 1275 1275
No Flow 1120 1120
Obstruction of Flow 1010 1010
Restricted Flow rate 1007 1007
Device Contamination with Chemical or Other Material 981 981
Defective Component 956 956
Backflow 934 934
Patient Device Interaction Problem 809 809
Adverse Event Without Identified Device or Use Problem 791 791
Connection Problem 790 790
Device Handling Problem 773 773
Free or Unrestricted Flow 754 754
Material Puncture/Hole 624 624
Improper Flow or Infusion 590 590
Audible Prompt/Feedback Problem 481 481
Material Split, Cut or Torn 423 423
Activation Problem 419 419
Inaccurate Delivery 397 397
Tear, Rip or Hole in Device Packaging 378 378
Excess Flow or Over-Infusion 354 354
Loose or Intermittent Connection 327 327
Failure to Prime 327 327
Defective Device 324 324
Mechanical Problem 321 321
Filling Problem 313 313
Product Quality Problem 307 307
Component Missing 297 297
Contamination /Decontamination Problem 284 284
Insufficient Information 270 270
Failure to Infuse 268 268
Physical Resistance/Sticking 239 239
Contamination 238 238
Separation Problem 227 227
Output Problem 207 207
False Alarm 190 190

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58063 58064
Hyperglycemia 16770 16770
No Consequences Or Impact To Patient 10897 10906
Diabetic Ketoacidosis 4433 4433
No Known Impact Or Consequence To Patient 3667 3667
Insufficient Information 3239 3239
No Information 2500 2502
No Patient Involvement 2247 2249
Chemical Exposure 810 810
Hypoglycemia 628 628
Hemorrhage/Bleeding 553 553
Unspecified Infection 455 455
Pain 401 401
Skin Inflammation/ Irritation 367 367
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 342 342
Low Blood Pressure/ Hypotension 221 221
Erythema 211 211
Needle Stick/Puncture 204 204
Blood Loss 162 162
Inflammation 95 95
Inadequate Pain Relief 88 88
Headache 85 85
Hypersensitivity/Allergic reaction 81 81
Pulmonary Hypertension 81 81
Exposure to Body Fluids 80 80
Itching Sensation 79 79
Nausea 79 79
Unspecified Tissue Injury 77 77
Swelling/ Edema 75 75
Vomiting 75 75
Local Reaction 71 71
Dyspnea 67 67
Underdose 67 67
No Code Available 62 62
Contact Dermatitis 61 61
Tissue Breakdown 58 58
Dizziness 55 55
Discomfort 52 52
High Blood Pressure/ Hypertension 47 47
Fatigue 46 46
Cardiac Arrest 43 43
Therapeutic Response, Decreased 43 43
Air Embolism 42 42
Tachycardia 40 40
Cellulitis 39 39
Death 33 33
Fever 33 33
Diarrhea 31 31
Foreign Body In Patient 31 31
Low Oxygen Saturation 30 30

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 Jan-22-2025
15 Baxter Healthcare Corporation II Mar-14-2024
16 Baxter Healthcare Corporation I Sep-14-2022
17 Baxter Healthcare Corporation II Feb-09-2021
18 Baxter Healthcare Corporation II Jan-09-2020
19 Becton Dickinson & Company II Nov-17-2023
20 Becton Dickinson & Company II Nov-04-2019
21 Becton Dickinson & Company II Oct-07-2019
22 Becton Dickinson & Company I Jul-11-2019
23 Becton Dickinson & Company I Jun-26-2019
24 Becton Dickinson & Company II Apr-10-2019
25 CAREFUSION II Sep-13-2022
26 CAREFUSION II Sep-13-2021
27 CAREFUSION II Jul-01-2021
28 CME America, LLC I Jul-15-2020
29 CME America, LLC II May-04-2020
30 Codan US Corporation II Jun-26-2020
31 Fresenius Kabi USA, LLC I Sep-04-2024
32 ICU Medical, Inc. II Sep-09-2022
33 ICU Medical, Inc. II May-13-2021
34 ICU Medical, Inc. II Dec-23-2020
35 ICU Medical, Inc. II Oct-22-2020
36 ICU Medical, Inc. II May-06-2020
37 ICU Medical, Inc. I Apr-15-2019
38 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
39 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
40 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
41 Molded Products Inc II Aug-22-2019
42 Quest Medical, Inc. II Oct-28-2023
43 Quest Medical, Inc. II Feb-07-2023
44 Repro-Med Systems, Inc. II Oct-07-2019
45 Smiths Medical ASD Inc. II Oct-18-2024
46 Smiths Medical ASD Inc. I Jan-30-2023
47 Smiths Medical ASD Inc. II Oct-19-2021
48 Smiths Medical ASD Inc. II Oct-24-2019
49 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
50 Unomedical A/S II Sep-19-2024
51 Unomedical A/S II Apr-15-2024
52 Unomedical A/S I Nov-21-2023
53 Unomedical A/S II Sep-26-2022
54 Vygon U.S.A. II Apr-09-2019
55 Zyno Medical LLC II Jul-23-2019
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