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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 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FERT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAIR L.G.L
  SUBSTANTIALLY EQUIVALENT 2
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
DOUGLAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSAFETY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
PURACATH MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
RYMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 4
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 6459 6459
2018 6567 6567
2019 11214 11214
2020 9553 9553
2021 10395 10396
2022 7533 7533

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 15855 15855
Leak/Splash 7354 7354
Detachment of Device or Device Component 3847 3847
Device Alarm System 2882 2882
Break 2392 2392
Disconnection 2333 2333
Complete Blockage 1917 1918
Material Separation 1860 1860
Crack 1427 1427
Insufficient Flow or Under Infusion 1189 1189
Infusion or Flow Problem 1032 1032
Material Twisted/Bent 1028 1028
Restricted Flow rate 990 990
Device Contamination with Chemical or Other Material 864 864
No Flow 816 816
Loss of or Failure to Bond 779 779
Connection Problem 697 697
Material Deformation 633 633
Free or Unrestricted Flow 629 629
Backflow 593 593
Obstruction of Flow 592 592
Failure to Prime 522 522
Improper Flow or Infusion 495 495
Material Puncture/Hole 427 427
Failure To Adhere Or Bond 402 402
Adverse Event Without Identified Device or Use Problem 401 401
Device Operates Differently Than Expected 372 372
Audible Prompt/Feedback Problem 363 363
Bent 360 360
Filling Problem 318 318
Reflux within Device 312 312
Defective Component 306 306
Device Displays Incorrect Message 302 302
Excess Flow or Over-Infusion 290 290
Mechanical Problem 286 286
Material Split, Cut or Torn 283 283
Air/Gas in Device 281 281
Insufficient Information 278 278
Loose or Intermittent Connection 269 269
Physical Resistance/Sticking 224 224
Defective Device 203 203
Output Problem 195 195
Component Missing 189 189
Detachment Of Device Component 189 189
Contamination /Decontamination Problem 188 188
Hole In Material 182 182
Occlusion Within Device 173 173
Protective Measures Problem 163 163
Tear, Rip or Hole in Device Packaging 160 160
Failure to Infuse 152 152
False Alarm 143 143
Inaccurate Delivery 141 141
Activation Problem 137 137
Material Fragmentation 125 125
Partial Blockage 123 123
Kinked 122 122
Stretched 119 119
Failure to Disconnect 115 115
Device Dislodged or Dislocated 110 110
Failure to Deliver 108 108
Packaging Problem 107 107
Material Integrity Problem 103 103
Material Rupture 101 101
Improper or Incorrect Procedure or Method 95 95
Appropriate Term/Code Not Available 94 94
Fitting Problem 93 93
Fracture 83 83
Volume Accuracy Problem 79 79
Difficult to Remove 72 72
Separation Failure 72 72
Device Damaged Prior to Use 71 71
Separation Problem 71 71
Pressure Problem 69 69
Deformation Due to Compressive Stress 67 67
Manufacturing, Packaging or Shipping Problem 65 65
Device Misassembled During Manufacturing /Shipping 65 65
Inaccurate Flow Rate 65 65
Flushing Problem 64 64
Difficult to Flush 63 63
Failure to Sense 62 62
Gas Leak 62 62
Device Sensing Problem 59 59
Unsealed Device Packaging 58 58
Retraction Problem 56 56
Contamination 53 53
Increase in Pressure 52 52
Incomplete or Inadequate Connection 52 52
Device Markings/Labelling Problem 50 50
Air Leak 49 49
Use of Device Problem 48 48
Priming Problem 47 47
Product Quality Problem 41 41
Delivered as Unsterile Product 41 41
Fail-Safe Did Not Operate 40 40
No Apparent Adverse Event 39 39
Material Discolored 38 38
Difficult or Delayed Separation 38 38
Patient Device Interaction Problem 38 38
Therapeutic or Diagnostic Output Failure 36 36
Difficult or Delayed Activation 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16350 16359
No Clinical Signs, Symptoms or Conditions 14147 14148
No Known Impact Or Consequence To Patient 7378 7378
No Patient Involvement 3223 3225
Hyperglycemia 3103 3103
No Information 2796 2798
Insufficient Information 1783 1783
Diabetic Ketoacidosis 1139 1139
Chemical Exposure 532 532
Blood Loss 260 260
Unspecified Infection 163 163
Low Blood Pressure/ Hypotension 149 149
Complaint, Ill-Defined 146 146
Underdose 142 142
Device Embedded In Tissue or Plaque 137 137
No Code Available 135 135
Hypoglycemia 130 130
Pain 128 128
Inadequate Pain Relief 121 121
Needle Stick/Puncture 110 110
Hemorrhage/Bleeding 95 95
Therapeutic Response, Decreased 84 84
Death 78 78
Not Applicable 62 62
Dyspnea 58 58
Inflammation 54 54
Exposure to Body Fluids 52 52
High Blood Pressure/ Hypertension 47 47
Nausea 47 47
Vomiting 46 46
Fever 43 43
Air Embolism 40 40
Bacterial Infection 40 40
Patient Problem/Medical Problem 40 40
Coma 36 36
Foreign Body In Patient 35 35
Erythema 34 34
Headache 33 33
Rash 30 30
Missed Dose 30 30
Skin Irritation 29 29
Cardiac Arrest 29 29
Venipuncture 28 28
Reaction, Injection Site 27 27
Loss of consciousness 25 25
Discomfort 24 24
Injury 24 24
Fatigue 24 24
Swelling 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Hypersensitivity/Allergic reaction 22 22
Skin Inflammation/ Irritation 21 21
Low Oxygen Saturation 20 20
Overdose 20 20
Diarrhea 18 18
Skin Inflammation 18 18
Bradycardia 17 17
Hepatitis 17 17
Tachycardia 17 17
Anxiety 17 17
Tissue Damage 17 17
Dizziness 17 17
Therapeutic Effects, Unexpected 15 15
Hypoxia 15 15
Respiratory Distress 14 14
Sepsis 14 14
Infiltration into Tissue 14 14
Cellulitis 14 14
Abscess 14 14
Apnea 12 12
Extravasation 12 12
Burning Sensation 11 11
Injection Site Reaction 11 11
Malaise 10 10
Irritation 10 10
Skin Discoloration 9 9
Weakness 9 9
Dehydration 9 9
Reaction 9 9
Lethargy 9 9
Tissue Breakdown 9 9
Increased Respiratory Rate 8 8
Hematoma 8 8
Hemolysis 8 8
Therapeutic Response, Increased 8 8
Seizures 8 8
Neurological Deficit/Dysfunction 8 8
Electrolyte Imbalance 7 7
Chest Pain 7 7
Bruise/Contusion 7 7
Chest Tightness/Pressure 7 7
Shaking/Tremors 6 6
Respiratory Failure 6 6
Test Result 6 6
Stroke/CVA 6 6
Cardiopulmonary Arrest 6 6
Awareness during Anaesthesia 6 6
Chills 6 6
Brain Injury 6 6
Itching Sensation 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Mar-29-2017
2 B Braun Medical Inc II May-23-2017
3 B. Braun Medical, Inc. II Sep-24-2021
4 B. Braun Medical, Inc. II Jul-23-2021
5 B. Braun Medical, Inc. II Apr-29-2021
6 B. Braun Medical, Inc. II Feb-02-2020
7 B. Braun Medical, Inc. I Sep-23-2019
8 B. Braun Medical, Inc. II Jun-25-2018
9 BD SWITZERLAND SARL II May-13-2020
10 Bard Access Systems II Jan-10-2017
11 Baxter Healthcare Corporation II Feb-09-2021
12 Baxter Healthcare Corporation II Jan-09-2020
13 Bayer Medical Care, Inc. II Oct-11-2018
14 Becton Dickinson & Company II Nov-04-2019
15 Becton Dickinson & Company II Oct-07-2019
16 Becton Dickinson & Company I Jul-11-2019
17 Becton Dickinson & Company I Jun-26-2019
18 Becton Dickinson & Company II Apr-10-2019
19 Becton Dickinson & Company II Nov-04-2018
20 Becton Dickinson & Company II May-01-2017
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 CareFusion 303, Inc. II Nov-04-2018
26 CareFusion 303, Inc. II Jun-07-2018
27 CareFusion 303, Inc. II Aug-11-2017
28 CareFusion 303, Inc. II Apr-27-2017
29 CareFusion 303, Inc. II Feb-28-2017
30 CareFusion 303, Inc. II Feb-28-2017
31 Codan US Corporation II Jun-26-2020
32 ConMed Corporation II Feb-28-2018
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 ICU Medical, Inc. II Jan-10-2017
39 Medtronic Inc. II Jul-05-2018
40 Medtronic Inc. II Nov-18-2017
41 Molded Products Inc II Aug-22-2019
42 Repro-Med Systems, Inc. II Oct-07-2019
43 Repro-Med Systems, Inc. II Jan-05-2018
44 Smiths Medical ASD Inc. II Oct-19-2021
45 Smiths Medical ASD Inc. II Oct-24-2019
46 Smiths Medical ASD Inc. II Oct-11-2018
47 Smiths Medical ASD Inc. II Jul-24-2017
48 Smiths Medical ASD Inc. II Mar-30-2017
49 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
50 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
51 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
52 Vygon U.S.A. II Apr-09-2019
53 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
54 Zyno Medical LLC II Jul-23-2019
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