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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
Product CodeFPA
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
410 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BQ PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  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
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDSAFETY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
NP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PURACATH MEDICAL, INC
  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
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 3
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 6567 6567
2019 11214 11214
2020 9553 9553
2021 10395 10396
2022 13401 13401

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 15053 15053
Leak/Splash 7145 7145
Detachment of Device or Device Component 4062 4062
Device Alarm System 3568 3568
Break 2219 2219
Complete Blockage 2162 2163
Disconnection 1988 1988
Material Separation 1843 1843
Crack 1247 1247
Insufficient Flow or Under Infusion 1200 1200
Material Twisted/Bent 1156 1156
Restricted Flow rate 992 992
Infusion or Flow Problem 991 991
Device Contamination with Chemical or Other Material 851 851
Loss of or Failure to Bond 846 846
Connection Problem 743 743
Obstruction of Flow 731 731
No Flow 700 700
Backflow 667 667
Free or Unrestricted Flow 637 637
Material Deformation 564 564
Patient Device Interaction Problem 542 542
Air/Gas in Device 503 503
Improper Flow or Infusion 499 499
Audible Prompt/Feedback Problem 476 476
Material Puncture/Hole 470 470
Defective Component 386 386
Failure to Prime 361 361
Filling Problem 304 304
Material Split, Cut or Torn 302 302
Excess Flow or Over-Infusion 298 298
Mechanical Problem 292 292
Adverse Event Without Identified Device or Use Problem 278 278
Insufficient Information 269 269
Defective Device 259 259
Loose or Intermittent Connection 239 239
Physical Resistance/Sticking 234 234
Device Displays Incorrect Message 223 223
Contamination /Decontamination Problem 203 203
Output Problem 202 202
Component Missing 182 182
Inaccurate Delivery 176 176
Activation Problem 170 170
Reflux within Device 169 169
False Alarm 163 163
Tear, Rip or Hole in Device Packaging 157 157
Failure to Infuse 142 142
Protective Measures Problem 137 137
Device Operates Differently Than Expected 121 121
Stretched 117 117
Failure to Deliver 115 115
Failure To Adhere Or Bond 107 107
Failure to Disconnect 103 103
Patient-Device Incompatibility 102 102
Packaging Problem 100 100
Separation Problem 99 99
Fitting Problem 98 98
Device Misassembled During Manufacturing /Shipping 95 95
Bent 88 88
Material Integrity Problem 87 87
Material Rupture 87 87
Device Dislodged or Dislocated 85 85
Appropriate Term/Code Not Available 84 84
Volume Accuracy Problem 82 82
Material Fragmentation 82 82
Fracture 80 80
Deformation Due to Compressive Stress 75 75
Difficult to Flush 72 72
Pressure Problem 72 72
Difficult to Remove 71 71
Device Damaged Prior to Use 71 71
Hole In Material 69 69
Inaccurate Flow Rate 68 68
Separation Failure 66 66
Gas/Air Leak 66 66
Contamination 65 65
Priming Problem 63 63
Failure to Sense 62 62
Device Sensing Problem 60 60
Increase in Pressure 60 60
Incomplete or Inadequate Connection 58 58
Improper or Incorrect Procedure or Method 58 58
Device Markings/Labelling Problem 57 57
Flushing Problem 57 57
Retraction Problem 56 56
Product Quality Problem 55 55
Detachment Of Device Component 55 55
Partial Blockage 54 54
Use of Device Problem 51 51
Material Discolored 45 45
Fail-Safe Did Not Operate 41 41
Difficult or Delayed Separation 40 40
Occlusion Within Device 40 40
No Apparent Adverse Event 37 37
Therapeutic or Diagnostic Output Failure 37 37
Delivered as Unsterile Product 36 36
Particulates 35 35
Device Difficult to Setup or Prepare 34 34
Misassembled 33 33
Difficult or Delayed Activation 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18886 18887
No Consequences Or Impact To Patient 14155 14164
No Known Impact Or Consequence To Patient 5451 5451
No Information 2672 2674
No Patient Involvement 2619 2621
Hyperglycemia 2328 2328
Insufficient Information 1894 1894
Diabetic Ketoacidosis 1187 1187
Chemical Exposure 552 552
Blood Loss 234 234
Pain 177 177
Erythema 164 164
Low Blood Pressure/ Hypotension 132 132
Unspecified Infection 128 128
Inadequate Pain Relief 117 117
Needle Stick/Puncture 114 114
Hemorrhage/Bleeding 105 105
No Code Available 98 98
Skin Inflammation/ Irritation 95 95
Hypoglycemia 88 88
Underdose 79 79
Therapeutic Response, Decreased 74 74
Death 56 56
Inflammation 56 56
Exposure to Body Fluids 56 56
Itching Sensation 52 52
Dyspnea 52 52
Swelling/ Edema 51 51
Headache 46 46
High Blood Pressure/ Hypertension 44 44
Nausea 44 44
Local Reaction 43 43
Unspecified Tissue Injury 39 39
Foreign Body In Patient 35 35
Patient Problem/Medical Problem 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Contact Dermatitis 34 34
Cardiac Arrest 33 33
Vomiting 32 32
Air Embolism 32 32
Rash 30 30
Cellulitis 30 30
Device Embedded In Tissue or Plaque 29 29
Venipuncture 28 28
Discomfort 28 28
Reaction, Injection Site 26 26
Skin Disorders 26 26
Low Oxygen Saturation 25 25
Fatigue 25 25
Hypersensitivity/Allergic reaction 24 24
Fever 23 23
Extravasation 23 23
Anxiety 23 23
Diarrhea 23 23
Bacterial Infection 22 22
Swelling 21 21
Coma 21 21
Skin Irritation 20 20
Dizziness 19 19
Tachycardia 18 18
Injury 18 18
Nodule 18 18
Infiltration into Tissue 18 18
Overdose 18 18
Injection Site Reaction 18 18
Sepsis 17 17
Hepatitis 17 17
Abscess 16 16
Missed Dose 16 16
Loss of consciousness 15 15
Skin Inflammation 15 15
Tissue Damage 15 15
Skin Discoloration 15 15
Therapeutic Effects, Unexpected 15 15
Complaint, Ill-Defined 15 15
Bradycardia 14 14
Bruise/Contusion 14 14
Hypoxia 13 13
Hematoma 12 12
Tissue Breakdown 12 12
Lethargy 12 12
Subcutaneous Nodule 11 11
Not Applicable 11 11
Apnea 10 10
Malaise 10 10
Reaction to Medicinal Component of Device 9 9
Reaction 9 9
Chest Pain 9 9
Respiratory Distress 9 9
Weakness 8 8
Burning Sensation 8 8
Neurological Deficit/Dysfunction 8 8
Therapeutic Response, Increased 8 8
Increased Respiratory Rate 8 8
Stroke/CVA 7 7
Awareness during Anaesthesia 7 7
Electrolyte Imbalance 7 7
Dehydration 6 6
Pallor 6 6
Hot Flashes/Flushes 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Nov-08-2022
2 B. Braun Medical, Inc. II Oct-14-2022
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 Baxter Healthcare Corporation I Sep-14-2022
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 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 CareFusion 303, Inc. II Nov-04-2018
26 CareFusion 303, Inc. II Jun-07-2018
27 Codan US Corporation II Jun-26-2020
28 ConMed Corporation II Feb-28-2018
29 ICU Medical, Inc. II Sep-09-2022
30 ICU Medical, Inc. II May-13-2021
31 ICU Medical, Inc. II Dec-23-2020
32 ICU Medical, Inc. II Oct-22-2020
33 ICU Medical, Inc. II May-06-2020
34 ICU Medical, Inc. I Apr-15-2019
35 Medtronic Inc. II Jul-05-2018
36 Molded Products Inc II Aug-22-2019
37 Repro-Med Systems, Inc. II Oct-07-2019
38 Repro-Med Systems, Inc. II Jan-05-2018
39 Smiths Medical ASD Inc. I Jan-30-2023
40 Smiths Medical ASD Inc. II Oct-19-2021
41 Smiths Medical ASD Inc. II Oct-24-2019
42 Smiths Medical ASD Inc. II Oct-11-2018
43 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
44 Unomedical A/S II Sep-26-2022
45 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
46 Vygon U.S.A. II Apr-09-2019
47 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
48 Zyno Medical LLC II Jul-23-2019
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