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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 2
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 8982 8982

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 16050 16050
Leak/Splash 7504 7504
Detachment of Device or Device Component 3920 3920
Device Alarm System 3251 3251
Break 2425 2425
Disconnection 2352 2352
Complete Blockage 1969 1970
Material Separation 1918 1918
Crack 1440 1440
Insufficient Flow or Under Infusion 1233 1233
Infusion or Flow Problem 1045 1045
Material Twisted/Bent 1043 1043
Restricted Flow rate 991 991
Device Contamination with Chemical or Other Material 873 873
No Flow 826 826
Loss of or Failure to Bond 796 796
Connection Problem 710 710
Material Deformation 639 639
Free or Unrestricted Flow 633 633
Backflow 618 618
Obstruction of Flow 611 611
Failure to Prime 530 530
Improper Flow or Infusion 503 503
Audible Prompt/Feedback Problem 472 472
Material Puncture/Hole 434 434
Adverse Event Without Identified Device or Use Problem 403 403
Failure To Adhere Or Bond 402 402
Device Operates Differently Than Expected 372 372
Bent 360 360
Air/Gas in Device 343 343
Defective Component 332 332
Filling Problem 322 322
Reflux within Device 312 312
Excess Flow or Over-Infusion 307 307
Device Displays Incorrect Message 305 305
Mechanical Problem 288 288
Material Split, Cut or Torn 283 283
Insufficient Information 282 282
Loose or Intermittent Connection 273 273
Physical Resistance/Sticking 225 225
Defective Device 217 217
Output Problem 199 199
Contamination /Decontamination Problem 193 193
Component Missing 193 193
Detachment Of Device Component 189 189
Hole In Material 182 182
Occlusion Within Device 173 173
Inaccurate Delivery 169 169
Protective Measures Problem 168 168
Failure to Infuse 163 163
Tear, Rip or Hole in Device Packaging 162 162
False Alarm 159 159
Activation Problem 140 140
Partial Blockage 127 127
Material Fragmentation 125 125
Kinked 122 122
Stretched 119 119
Failure to Deliver 119 119
Failure to Disconnect 117 117
Device Dislodged or Dislocated 111 111
Packaging Problem 109 109
Material Integrity Problem 103 103
Material Rupture 101 101
Appropriate Term/Code Not Available 95 95
Improper or Incorrect Procedure or Method 95 95
Fitting Problem 93 93
Device Misassembled During Manufacturing /Shipping 86 86
Fracture 85 85
Volume Accuracy Problem 79 79
Separation Problem 75 75
Device Damaged Prior to Use 73 73
Separation Failure 72 72
Difficult to Remove 72 72
Pressure Problem 70 70
Deformation Due to Compressive Stress 68 68
Inaccurate Flow Rate 68 68
Flushing Problem 65 65
Manufacturing, Packaging or Shipping Problem 65 65
Difficult to Flush 64 64
Gas Leak 63 63
Failure to Sense 62 62
Unsealed Device Packaging 59 59
Device Sensing Problem 59 59
Retraction Problem 56 56
Priming Problem 56 56
Contamination 55 55
Incomplete or Inadequate Connection 53 53
Increase in Pressure 52 52
Device Markings/Labelling Problem 51 51
Product Quality Problem 49 49
Use of Device Problem 49 49
Air Leak 49 49
Patient Device Interaction Problem 43 43
Delivered as Unsterile Product 42 42
Fail-Safe Did Not Operate 41 41
Difficult or Delayed Separation 40 40
No Apparent Adverse Event 40 40
Material Discolored 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 15479 15480
No Known Impact Or Consequence To Patient 7378 7378
No Patient Involvement 3223 3225
Hyperglycemia 3145 3145
No Information 2796 2798
Insufficient Information 1813 1813
Diabetic Ketoacidosis 1149 1149
Chemical Exposure 539 539
Blood Loss 260 260
Unspecified Infection 164 164
Low Blood Pressure/ Hypotension 154 154
Complaint, Ill-Defined 146 146
Underdose 142 142
Device Embedded In Tissue or Plaque 137 137
Pain 136 136
No Code Available 135 135
Hypoglycemia 132 132
Inadequate Pain Relief 121 121
Needle Stick/Puncture 110 110
Hemorrhage/Bleeding 99 99
Therapeutic Response, Decreased 84 84
Death 78 78
Dyspnea 63 63
Not Applicable 62 62
Inflammation 54 54
Exposure to Body Fluids 52 52
Nausea 48 48
High Blood Pressure/ Hypertension 47 47
Vomiting 46 46
Fever 43 43
Headache 40 40
Air Embolism 40 40
Bacterial Infection 40 40
Patient Problem/Medical Problem 40 40
Erythema 37 37
Coma 36 36
Foreign Body In Patient 35 35
Cardiac Arrest 32 32
Rash 31 31
Missed Dose 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Skin Irritation 29 29
Venipuncture 28 28
Reaction, Injection Site 27 27
Loss of consciousness 26 26
Low Oxygen Saturation 25 25
Injury 24 24
Discomfort 24 24
Fatigue 24 24
Swelling 23 23
Hypersensitivity/Allergic reaction 22 22
Skin Inflammation/ Irritation 22 22
Diarrhea 20 20
Overdose 20 20
Anxiety 18 18
Skin Inflammation 18 18
Dizziness 17 17
Tissue Damage 17 17
Tachycardia 17 17
Bradycardia 17 17
Hepatitis 17 17
Cellulitis 16 16
Sepsis 16 16
Therapeutic Effects, Unexpected 15 15
Hypoxia 15 15
Respiratory Distress 14 14
Infiltration into Tissue 14 14
Abscess 14 14
Apnea 12 12
Extravasation 12 12
Tissue Breakdown 12 12
Injection Site Reaction 12 12
Lethargy 11 11
Burning Sensation 11 11
Malaise 10 10
Irritation 10 10
Skin Discoloration 10 10
Weakness 9 9
Dehydration 9 9
Reaction 9 9
Increased Respiratory Rate 8 8
Chest Pain 8 8
Bruise/Contusion 8 8
Hematoma 8 8
Hemolysis 8 8
Seizures 8 8
Therapeutic Response, Increased 8 8
Neurological Deficit/Dysfunction 8 8
Itching Sensation 7 7
Electrolyte Imbalance 7 7
Chest Tightness/Pressure 7 7
Shaking/Tremors 6 6
Respiratory Failure 6 6
Pallor 6 6
Test Result 6 6
Syncope/Fainting 6 6
Chills 6 6
Brain Injury 6 6
Local Reaction 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 I Sep-14-2022
12 Baxter Healthcare Corporation II Feb-09-2021
13 Baxter Healthcare Corporation II Jan-09-2020
14 Bayer Medical Care, Inc. II Oct-11-2018
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 Becton Dickinson & Company II Nov-04-2018
21 Becton Dickinson & Company II May-01-2017
22 CAREFUSION II Sep-13-2022
23 CAREFUSION II Sep-13-2021
24 CAREFUSION II Jul-01-2021
25 CME America, LLC I Jul-15-2020
26 CME America, LLC II May-04-2020
27 CareFusion 303, Inc. II Nov-04-2018
28 CareFusion 303, Inc. II Jun-07-2018
29 CareFusion 303, Inc. II Aug-11-2017
30 CareFusion 303, Inc. II Apr-27-2017
31 CareFusion 303, Inc. II Feb-28-2017
32 CareFusion 303, Inc. II Feb-28-2017
33 Codan US Corporation II Jun-26-2020
34 ConMed Corporation II Feb-28-2018
35 ICU Medical, Inc. II Sep-09-2022
36 ICU Medical, Inc. II May-13-2021
37 ICU Medical, Inc. II Dec-23-2020
38 ICU Medical, Inc. II Oct-22-2020
39 ICU Medical, Inc. II May-06-2020
40 ICU Medical, Inc. I Apr-15-2019
41 ICU Medical, Inc. II Jan-10-2017
42 Medtronic Inc. II Jul-05-2018
43 Medtronic Inc. II Nov-18-2017
44 Molded Products Inc II Aug-22-2019
45 Repro-Med Systems, Inc. II Oct-07-2019
46 Repro-Med Systems, Inc. II Jan-05-2018
47 Smiths Medical ASD Inc. II Oct-19-2021
48 Smiths Medical ASD Inc. II Oct-24-2019
49 Smiths Medical ASD Inc. II Oct-11-2018
50 Smiths Medical ASD Inc. II Jul-24-2017
51 Smiths Medical ASD Inc. II Mar-30-2017
52 Stradis Medical, LLC dba Stradis Healthcare II Dec-20-2021
53 Unomedical A/S II Sep-26-2022
54 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
55 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
56 Vygon U.S.A. II Apr-09-2019
57 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
58 Zyno Medical LLC II Jul-23-2019
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