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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
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 10918 10918
2024 2239 2239

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 15221 15221
Leak/Splash 8360 8360
Detachment of Device or Device Component 4537 4537
Device Alarm System 4418 4418
Complete Blockage 2921 2922
Break 2255 2255
Material Separation 1950 1950
Disconnection 1929 1929
Crack 1522 1522
Material Twisted/Bent 1382 1382
Insufficient Flow or Under Infusion 1319 1319
Air/Gas in Device 1267 1267
Infusion or Flow Problem 1085 1085
Restricted Flow rate 1003 1003
Loss of or Failure to Bond 928 928
Obstruction of Flow 913 913
No Flow 910 910
Device Contamination with Chemical or Other Material 883 883
Backflow 837 837
Patient Device Interaction Problem 809 809
Connection Problem 745 745
Defective Component 721 721
Free or Unrestricted Flow 673 673
Improper Flow or Infusion 562 562
Material Deformation 548 548
Material Puncture/Hole 545 545
Audible Prompt/Feedback Problem 481 481
Inaccurate Delivery 377 377
Activation Problem 339 339
Material Split, Cut or Torn 331 331
Failure to Prime 317 317
Defective Device 299 299
Excess Flow or Over-Infusion 298 298
Mechanical Problem 296 296
Loose or Intermittent Connection 292 292
Filling Problem 286 286
Product Quality Problem 283 283
Adverse Event Without Identified Device or Use Problem 264 264
Insufficient Information 248 248
Component Missing 246 246
Physical Resistance/Sticking 224 224
Contamination /Decontamination Problem 218 218
Output Problem 206 206
False Alarm 180 180
Failure to Infuse 171 171
Tear, Rip or Hole in Device Packaging 170 170
Separation Problem 170 170
Protective Measures Problem 160 160
Patient-Device Incompatibility 143 143
Contamination 142 142
Failure to Disconnect 114 114
Failure to Deliver 112 112
Stretched 112 112
Fitting Problem 111 111
Device Misassembled During Manufacturing /Shipping 107 107
Deformation Due to Compressive Stress 106 106
Packaging Problem 106 106
Device Dislodged or Dislocated 105 105
Partial Blockage 97 97
Material Rupture 92 92
Pressure Problem 92 92
Volume Accuracy Problem 91 91
Difficult to Flush 89 89
Incomplete or Inadequate Connection 89 89
Material Integrity Problem 89 89
Appropriate Term/Code Not Available 87 87
Material Fragmentation 86 86
Inaccurate Flow Rate 84 84
Fracture 80 80
Reflux within Device 80 80
Difficult to Remove 80 80
Increase in Pressure 79 79
Separation Failure 79 79
Gas/Air Leak 76 76
Priming Problem 75 75
Device Damaged Prior to Use 71 71
Device Markings/Labelling Problem 70 70
Flushing Problem 68 68
Failure to Sense 63 63
Device Sensing Problem 61 61
Retraction Problem 60 60
Device Displays Incorrect Message 59 59
Improper or Incorrect Procedure or Method 53 53
Use of Device Problem 52 52
No Apparent Adverse Event 52 52
Material Discolored 51 51
Difficult or Delayed Activation 48 48
Device Difficult to Setup or Prepare 47 47
Particulates 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
Activation Failure 30 30
Unsealed Device Packaging 29 29
Blocked Connection 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29514 29515
No Consequences Or Impact To Patient 10897 10906
No Known Impact Or Consequence To Patient 3667 3667
Insufficient Information 2946 2946
No Information 2500 2502
No Patient Involvement 2247 2249
Hyperglycemia 2153 2153
Diabetic Ketoacidosis 1387 1387
Chemical Exposure 720 720
Pain 279 279
Hemorrhage/Bleeding 219 219
Erythema 207 207
Needle Stick/Puncture 169 169
Low Blood Pressure/ Hypotension 165 165
Blood Loss 162 162
Skin Inflammation/ Irritation 143 143
Unspecified Infection 114 114
Hypoglycemia 82 82
Inadequate Pain Relief 80 80
Inflammation 79 79
Itching Sensation 77 77
Unspecified Tissue Injury 77 77
Pulmonary Hypertension 77 77
Exposure to Body Fluids 72 72
Local Reaction 71 71
Headache 70 70
Swelling/ Edema 69 69
Underdose 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 66 66
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 39 39
Vomiting 38 38
Fatigue 36 36
Cellulitis 34 34
Death 33 33
Hypersensitivity/Allergic reaction 31 31
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
Awareness during Anaesthesia 16 16
Abscess 15 15
Tissue Damage 15 15
Skin Discoloration 15 15
Injury 15 15
Coma 15 15
Patient Problem/Medical Problem 15 15
Lethargy 14 14
Malaise 14 14
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 Molded Products Inc II Aug-22-2019
34 Quest Medical, Inc. II Oct-28-2023
35 Quest Medical, Inc. II Feb-07-2023
36 Repro-Med Systems, Inc. II Oct-07-2019
37 Smiths Medical ASD Inc. I Jan-30-2023
38 Smiths Medical ASD Inc. II Oct-19-2021
39 Smiths Medical ASD Inc. II Oct-24-2019
40 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
41 Unomedical A/S II Apr-15-2024
42 Unomedical A/S I Nov-21-2023
43 Unomedical A/S II Sep-26-2022
44 Vygon U.S.A. II Apr-09-2019
45 Zyno Medical LLC II Jul-23-2019
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