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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 1
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
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 10914 10914
2024 808 808

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 14826 14826
Leak/Splash 8191 8191
Detachment of Device or Device Component 4463 4463
Device Alarm System 4338 4338
Complete Blockage 2874 2875
Break 2230 2230
Disconnection 1908 1908
Material Separation 1906 1906
Crack 1468 1468
Material Twisted/Bent 1328 1328
Insufficient Flow or Under Infusion 1307 1307
Air/Gas in Device 1114 1114
Infusion or Flow Problem 1060 1060
Restricted Flow rate 1001 1001
Loss of or Failure to Bond 905 905
Obstruction of Flow 905 905
Device Contamination with Chemical or Other Material 877 877
No Flow 864 864
Backflow 810 810
Patient Device Interaction Problem 809 809
Connection Problem 732 732
Defective Component 668 668
Free or Unrestricted Flow 662 662
Improper Flow or Infusion 553 553
Material Deformation 542 542
Material Puncture/Hole 538 538
Audible Prompt/Feedback Problem 481 481
Inaccurate Delivery 376 376
Material Split, Cut or Torn 325 325
Activation Problem 322 322
Failure to Prime 317 317
Defective Device 298 298
Mechanical Problem 296 296
Excess Flow or Over-Infusion 289 289
Loose or Intermittent Connection 286 286
Filling Problem 283 283
Product Quality Problem 282 282
Adverse Event Without Identified Device or Use Problem 259 259
Insufficient Information 245 245
Component Missing 242 242
Physical Resistance/Sticking 223 223
Contamination /Decontamination Problem 215 215
Output Problem 206 206
False Alarm 179 179
Failure to Infuse 169 169
Tear, Rip or Hole in Device Packaging 167 167
Protective Measures Problem 155 155
Separation Problem 147 147
Patient-Device Incompatibility 143 143
Contamination 136 136
Failure to Disconnect 113 113
Fitting Problem 111 111
Stretched 110 110
Failure to Deliver 110 110
Device Misassembled During Manufacturing /Shipping 107 107
Deformation Due to Compressive Stress 104 104
Packaging Problem 102 102
Device Dislodged or Dislocated 98 98
Partial Blockage 95 95
Material Rupture 91 91
Pressure Problem 91 91
Volume Accuracy Problem 89 89
Difficult to Flush 88 88
Incomplete or Inadequate Connection 88 88
Material Fragmentation 86 86
Appropriate Term/Code Not Available 85 85
Material Integrity Problem 85 85
Inaccurate Flow Rate 84 84
Reflux within Device 80 80
Difficult to Remove 78 78
Fracture 77 77
Increase in Pressure 76 76
Gas/Air Leak 76 76
Priming Problem 74 74
Separation Failure 73 73
Device Damaged Prior to Use 71 71
Flushing Problem 68 68
Device Markings/Labelling Problem 64 64
Failure to Sense 63 63
Device Sensing Problem 61 61
Device Displays Incorrect Message 59 59
Retraction Problem 58 58
Improper or Incorrect Procedure or Method 52 52
Use of Device Problem 51 51
Material Discolored 51 51
No Apparent Adverse Event 51 51
Device Difficult to Setup or Prepare 47 47
Particulates 47 47
Misassembled 45 45
Fail-Safe Did Not Operate 44 44
Difficult or Delayed Separation 43 43
Difficult or Delayed Activation 42 42
Therapeutic or Diagnostic Output Failure 40 40
Manufacturing, Packaging or Shipping Problem 36 36
Component Misassembled 35 35
Defective Alarm 35 35
Delivered as Unsterile Product 31 31
Activation Failure 30 30
Unsealed Device Packaging 28 28
Blocked Connection 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28304 28305
No Consequences Or Impact To Patient 10897 10906
No Known Impact Or Consequence To Patient 3667 3667
Insufficient Information 2854 2854
No Information 2500 2502
No Patient Involvement 2247 2249
Hyperglycemia 2106 2106
Diabetic Ketoacidosis 1334 1334
Chemical Exposure 707 707
Pain 276 276
Erythema 206 206
Hemorrhage/Bleeding 205 205
Blood Loss 162 162
Needle Stick/Puncture 160 160
Low Blood Pressure/ Hypotension 157 157
Skin Inflammation/ Irritation 142 142
Unspecified Infection 114 114
Hypoglycemia 80 80
Inadequate Pain Relief 80 80
Inflammation 79 79
Unspecified Tissue Injury 77 77
Pulmonary Hypertension 77 77
Itching Sensation 75 75
Exposure to Body Fluids 72 72
Local Reaction 71 71
Headache 69 69
Swelling/ Edema 69 69
Underdose 67 67
No Code Available 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 58 58
Nausea 58 58
Contact Dermatitis 57 57
Dyspnea 55 55
High Blood Pressure/ Hypertension 43 43
Therapeutic Response, Decreased 43 43
Dizziness 41 41
Discomfort 41 41
Vomiting 38 38
Cardiac Arrest 38 38
Cellulitis 34 34
Death 33 33
Fatigue 32 32
Hypersensitivity/Allergic reaction 30 30
Tachycardia 30 30
Air Embolism 29 29
Foreign Body In Patient 29 29
Skin Disorders 29 29
Diarrhea 28 28
Low Oxygen Saturation 27 27
Extravasation 25 25
Fever 24 24
Anxiety 23 23
Reaction to Medicinal Component of Device 23 23
Rash 22 22
Sepsis 22 22
Bacterial Infection 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
Coma 15 15
Injury 15 15
Patient Problem/Medical Problem 15 15
Abscess 15 15
Tissue Damage 15 15
Skin Discoloration 15 15
Therapeutic Effects, Unexpected 14 14
Bradycardia 14 14
Exsanguination 14 14
Lethargy 14 14
Skin Inflammation 14 14
Malaise 14 14
Increased Respiratory Rate 14 14
Tissue Breakdown 13 13
Subcutaneous Nodule 13 13
Hematoma 13 13
Abdominal Pain 12 12
Awareness during Anaesthesia 12 12
Skin Irritation 12 12
Overdose 12 12
Missed Dose 12 12
Loss of consciousness 12 12
Hypoxia 11 11
Chest Pain 10 10
Hot Flashes/Flushes 10 10
Not Applicable 10 10
Syncope/Fainting 10 10
Apnea 9 9
Emotional Changes 9 9
Neurological Deficit/Dysfunction 8 8
Pallor 8 8
Unspecified Respiratory Problem 7 7
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 I Sep-14-2022
12 Baxter Healthcare Corporation II Feb-09-2021
13 Baxter Healthcare Corporation II Jan-09-2020
14 Becton Dickinson & Company II Nov-17-2023
15 Becton Dickinson & Company II Nov-04-2019
16 Becton Dickinson & Company II Oct-07-2019
17 Becton Dickinson & Company I Jul-11-2019
18 Becton Dickinson & Company I Jun-26-2019
19 Becton Dickinson & Company II Apr-10-2019
20 CAREFUSION II Sep-13-2022
21 CAREFUSION II Sep-13-2021
22 CAREFUSION II Jul-01-2021
23 CME America, LLC I Jul-15-2020
24 CME America, LLC II May-04-2020
25 Codan US Corporation II Jun-26-2020
26 ICU Medical, Inc. II Sep-09-2022
27 ICU Medical, Inc. II May-13-2021
28 ICU Medical, Inc. II Dec-23-2020
29 ICU Medical, Inc. II Oct-22-2020
30 ICU Medical, Inc. II May-06-2020
31 ICU Medical, Inc. I Apr-15-2019
32 Molded Products Inc II Aug-22-2019
33 Quest Medical, Inc. II Oct-28-2023
34 Quest Medical, Inc. II Feb-07-2023
35 Repro-Med Systems, Inc. II Oct-07-2019
36 Smiths Medical ASD Inc. I Jan-30-2023
37 Smiths Medical ASD Inc. II Oct-19-2021
38 Smiths Medical ASD Inc. II Oct-24-2019
39 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
40 Unomedical A/S I Nov-21-2023
41 Unomedical A/S II Sep-26-2022
42 Vygon U.S.A. II Apr-09-2019
43 Zyno Medical LLC II Jul-23-2019
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