• 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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 3
CAREFUSION, INC.
  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 10919 10919
2024 3005 3005

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 15433 15433
Leak/Splash 8454 8454
Detachment of Device or Device Component 4561 4561
Device Alarm System 4474 4474
Complete Blockage 2949 2950
Break 2266 2266
Material Separation 1968 1968
Disconnection 1945 1945
Crack 1543 1543
Material Twisted/Bent 1394 1394
Air/Gas in Device 1338 1338
Insufficient Flow or Under Infusion 1325 1325
Infusion or Flow Problem 1118 1118
Restricted Flow rate 1006 1006
Loss of or Failure to Bond 949 949
No Flow 929 929
Obstruction of Flow 918 918
Device Contamination with Chemical or Other Material 889 889
Backflow 847 847
Patient Device Interaction Problem 809 809
Defective Component 755 755
Connection Problem 751 751
Free or Unrestricted Flow 679 679
Improper Flow or Infusion 562 562
Material Deformation 552 552
Material Puncture/Hole 552 552
Audible Prompt/Feedback Problem 481 481
Inaccurate Delivery 377 377
Activation Problem 347 347
Material Split, Cut or Torn 337 337
Failure to Prime 318 318
Defective Device 301 301
Excess Flow or Over-Infusion 300 300
Mechanical Problem 296 296
Loose or Intermittent Connection 295 295
Filling Problem 289 289
Product Quality Problem 283 283
Adverse Event Without Identified Device or Use Problem 264 264
Insufficient Information 255 255
Component Missing 250 250
Physical Resistance/Sticking 224 224
Contamination /Decontamination Problem 223 223
Output Problem 206 206
False Alarm 181 181
Failure to Infuse 174 174
Separation Problem 174 174
Tear, Rip or Hole in Device Packaging 172 172
Protective Measures Problem 164 164
Contamination 144 144
Patient-Device Incompatibility 143 143
Failure to Disconnect 114 114
Failure to Deliver 112 112
Fitting Problem 112 112
Stretched 112 112
Device Misassembled During Manufacturing /Shipping 108 108
Device Dislodged or Dislocated 107 107
Deformation Due to Compressive Stress 107 107
Packaging Problem 107 107
Partial Blockage 99 99
Pressure Problem 93 93
Appropriate Term/Code Not Available 92 92
Material Rupture 92 92
Volume Accuracy Problem 91 91
Material Integrity Problem 91 91
Difficult to Flush 90 90
Incomplete or Inadequate Connection 89 89
Inaccurate Flow Rate 86 86
Material Fragmentation 86 86
Difficult to Remove 84 84
Fracture 83 83
Reflux within Device 80 80
Increase in Pressure 79 79
Separation Failure 79 79
Gas/Air Leak 78 78
Priming Problem 75 75
Device Markings/Labelling Problem 72 72
Device Damaged Prior to Use 71 71
Flushing Problem 68 68
Failure to Sense 63 63
Retraction Problem 61 61
Device Sensing Problem 61 61
Device Displays Incorrect Message 59 59
No Apparent Adverse Event 53 53
Improper or Incorrect Procedure or Method 53 53
Use of Device Problem 52 52
Material Discolored 51 51
Difficult or Delayed Activation 49 49
Particulates 48 48
Device Difficult to Setup or Prepare 47 47
Misassembled 46 46
Difficult or Delayed Separation 44 44
Fail-Safe Did Not Operate 44 44
Component Misassembled 40 40
Therapeutic or Diagnostic Output Failure 40 40
Manufacturing, Packaging or Shipping Problem 37 37
Defective Alarm 35 35
Delivered as Unsterile Product 31 31
Unsealed Device Packaging 30 30
Activation Failure 30 30
Blocked Connection 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30146 30147
No Consequences Or Impact To Patient 10897 10906
No Known Impact Or Consequence To Patient 3667 3667
Insufficient Information 3002 3002
No Information 2500 2502
No Patient Involvement 2247 2249
Hyperglycemia 2178 2178
Diabetic Ketoacidosis 1408 1408
Chemical Exposure 734 734
Pain 279 279
Hemorrhage/Bleeding 229 229
Erythema 208 208
Needle Stick/Puncture 172 172
Low Blood Pressure/ Hypotension 171 171
Blood Loss 162 162
Skin Inflammation/ Irritation 144 144
Unspecified Infection 114 114
Hypoglycemia 82 82
Inflammation 80 80
Inadequate Pain Relief 80 80
Unspecified Tissue Injury 77 77
Pulmonary Hypertension 77 77
Itching Sensation 77 77
Exposure to Body Fluids 72 72
Local Reaction 71 71
Headache 70 70
Swelling/ Edema 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 67 67
Underdose 67 67
No Code Available 62 62
Nausea 58 58
Contact Dermatitis 57 57
Dyspnea 56 56
High Blood Pressure/ Hypertension 43 43
Therapeutic Response, Decreased 43 43
Discomfort 43 43
Dizziness 42 42
Cardiac Arrest 40 40
Vomiting 38 38
Fatigue 36 36
Cellulitis 34 34
Death 33 33
Hypersensitivity/Allergic reaction 32 32
Tachycardia 30 30
Foreign Body In Patient 30 30
Low Oxygen Saturation 29 29
Skin Disorders 29 29
Air Embolism 29 29
Diarrhea 28 28
Fever 26 26
Extravasation 26 26
Anxiety 26 26
Reaction to Medicinal Component of Device 23 23
Bacterial Infection 22 22
Rash 22 22
Sepsis 22 22
Injection Site Reaction 20 20
Device Embedded In Tissue or Plaque 20 20
Reaction, Injection Site 19 19
Nodule 19 19
Infiltration into Tissue 18 18
Swelling 17 17
Venipuncture 17 17
Bruise/Contusion 17 17
Hepatitis 17 17
Irritability 17 17
Malaise 16 16
Coma 16 16
Awareness during Anaesthesia 16 16
Abscess 16 16
Tissue Damage 15 15
Skin Discoloration 15 15
Injury 15 15
Patient Problem/Medical Problem 15 15
Lethargy 15 15
Skin Inflammation 14 14
Increased Respiratory Rate 14 14
Therapeutic Effects, Unexpected 14 14
Bradycardia 14 14
Exsanguination 14 14
Hematoma 13 13
Tissue Breakdown 13 13
Subcutaneous Nodule 13 13
Missed Dose 12 12
Loss of consciousness 12 12
Abdominal Pain 12 12
Skin Irritation 12 12
Overdose 12 12
Hypoxia 11 11
Hot Flashes/Flushes 11 11
Chest Pain 10 10
Not Applicable 10 10
Syncope/Fainting 10 10
Unspecified Respiratory Problem 10 10
Apnea 9 9
Emotional Changes 9 9
Neurological Deficit/Dysfunction 8 8
Pallor 8 8
Respiratory Distress 7 7
Burning Sensation 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Nov-08-2022
2 B. Braun Medical, Inc. I Dec-01-2023
3 B. Braun Medical, Inc. II Nov-03-2023
4 B. Braun Medical, Inc. II Oct-14-2022
5 B. Braun Medical, Inc. II Sep-24-2021
6 B. Braun Medical, Inc. II Jul-23-2021
7 B. Braun Medical, Inc. II Apr-29-2021
8 B. Braun Medical, Inc. II Feb-02-2020
9 B. Braun Medical, Inc. I Sep-23-2019
10 BD SWITZERLAND SARL II May-13-2020
11 Baxter Healthcare Corporation II Mar-14-2024
12 Baxter Healthcare Corporation I Sep-14-2022
13 Baxter Healthcare Corporation II Feb-09-2021
14 Baxter Healthcare Corporation II Jan-09-2020
15 Becton Dickinson & Company II Nov-17-2023
16 Becton Dickinson & Company II Nov-04-2019
17 Becton Dickinson & Company II Oct-07-2019
18 Becton Dickinson & Company I Jul-11-2019
19 Becton Dickinson & Company I Jun-26-2019
20 Becton Dickinson & Company II Apr-10-2019
21 CAREFUSION II Sep-13-2022
22 CAREFUSION II Sep-13-2021
23 CAREFUSION II Jul-01-2021
24 CME America, LLC I Jul-15-2020
25 CME America, LLC II May-04-2020
26 Codan US Corporation II Jun-26-2020
27 ICU Medical, Inc. II Sep-09-2022
28 ICU Medical, Inc. II May-13-2021
29 ICU Medical, Inc. II Dec-23-2020
30 ICU Medical, Inc. II Oct-22-2020
31 ICU Medical, Inc. II May-06-2020
32 ICU Medical, Inc. I Apr-15-2019
33 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
34 Molded Products Inc II Aug-22-2019
35 Quest Medical, Inc. II Oct-28-2023
36 Quest Medical, Inc. II Feb-07-2023
37 Repro-Med Systems, Inc. II Oct-07-2019
38 Smiths Medical ASD Inc. I Jan-30-2023
39 Smiths Medical ASD Inc. II Oct-19-2021
40 Smiths Medical ASD Inc. II Oct-24-2019
41 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
42 Unomedical A/S II Apr-15-2024
43 Unomedical A/S I Nov-21-2023
44 Unomedical A/S II Sep-26-2022
45 Vygon U.S.A. II Apr-09-2019
46 Zyno Medical LLC II Jul-23-2019
-
-