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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intravascular, therapeutic, short-term less than 30 days
Product CodeFOZ
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
B.BRAUN MELSUNGEN AG
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 3
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 6
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDIFIRST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS (INDIA) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE LABS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1964 1964
2018 3295 3295
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 1326 1326

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5961 5961
Device Contamination with Chemical or Other Material 2402 2402
Break 2233 2233
Retraction Problem 1178 1178
Fluid Leak 981 981
Material Separation 580 580
Material Deformation 568 568
Adverse Event Without Identified Device or Use Problem 500 500
Material Protrusion/Extrusion 474 474
Deformation Due to Compressive Stress 387 387
Crack 366 366
Detachment of Device or Device Component 339 339
Unraveled Material 299 299
Packaging Problem 254 254
Device Operates Differently Than Expected 231 231
Material Puncture/Hole 221 221
Physical Resistance/Sticking 219 219
Difficult to Remove 208 208
Difficult or Delayed Activation 198 198
Defective Component 190 190
Material Split, Cut or Torn 186 186
Difficult to Advance 176 176
Material Twisted/Bent 175 175
Dull, Blunt 168 168
Detachment Of Device Component 159 159
Kinked 158 158
Device Markings/Labelling Problem 155 155
Material Frayed 154 154
Unsealed Device Packaging 140 140
Component Missing 140 140
Fracture 137 137
Complete Blockage 132 132
Failure to Advance 130 130
Difficult to Insert 127 127
Device Damaged Prior to Use 122 122
Contamination /Decontamination Problem 121 121
Material Integrity Problem 115 115
Defective Device 112 112
Obstruction of Flow 112 112
Material Fragmentation 109 109
Delivered as Unsterile Product 101 101
Fail-Safe Problem 100 100
Protective Measures Problem 96 96
Activation Problem 91 91
Loose or Intermittent Connection 90 90
Material Rupture 86 86
Bent 84 84
Insufficient Information 84 84
Product Quality Problem 82 82
Entrapment of Device 81 81
Infusion or Flow Problem 81 81
Disconnection 75 75
Nonstandard Device 67 67
Sticking 67 67
Physical Resistance 65 65
Hole In Material 63 63
Improper or Incorrect Procedure or Method 60 60
Microbial Contamination of Device 59 59
Structural Problem 58 58
Patient-Device Incompatibility 54 54
Material Perforation 53 53
Occlusion Within Device 46 46
Mechanical Problem 45 45
Gas Leak 45 45
Appropriate Term/Code Not Available 45 45
Fail-Safe Did Not Operate 43 43
Device Dislodged or Dislocated 43 43
Activation, Positioning or SeparationProblem 43 43
Use of Device Problem 43 43
Difficult To Position 42 42
Fitting Problem 41 41
Difficult or Delayed Positioning 40 40
Failure to Deliver 39 39
Tear, Rip or Hole in Device Packaging 38 38
Free or Unrestricted Flow 37 37
Device Packaging Compromised 36 36
Material Discolored 36 36
Manufacturing, Packaging or Shipping Problem 33 33
Improper Flow or Infusion 31 31
Connection Problem 31 31
Contamination 31 31
Fail-Safe Design Failure 30 30
Flushing Problem 26 26
Split 26 26
Positioning Problem 26 26
Migration or Expulsion of Device 25 25
Partial Blockage 25 25
Problem with Sterilization 24 24
Difficult to Flush 23 23
Device Fell 22 22
Output Problem 21 21
Illegible Information 21 21
Therapeutic or Diagnostic Output Failure 20 20
Backflow 20 20
Device Slipped 20 20
Stretched 19 19
Degraded 19 19
Malposition of Device 19 19
Separation Problem 18 18
Burst Container or Vessel 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6767 6767
No Clinical Signs, Symptoms or Conditions 4698 4698
No Consequences Or Impact To Patient 3763 3763
No Patient Involvement 659 659
Foreign Body In Patient 522 522
No Information 472 472
Insufficient Information 391 391
No Code Available 344 344
Needle Stick/Puncture 335 335
Pain 307 307
Device Embedded In Tissue or Plaque 267 267
Blood Loss 174 174
Bacterial Infection 166 166
Exposure to Body Fluids 150 150
Unspecified Infection 108 108
Extravasation 107 107
Hemorrhage/Bleeding 101 101
Hypersensitivity/Allergic reaction 95 95
Swelling 86 86
Phlebitis 76 76
Infiltration into Tissue 66 66
Erythema 61 61
Hematoma 51 51
Death 46 46
Injury 46 46
Discomfort 42 42
Bruise/Contusion 38 38
Inflammation 37 37
Fever 34 34
Thrombosis/Thrombus 30 30
Thrombus 27 27
Thrombosis 26 26
Anaphylactic Shock 26 26
Swelling/ Edema 25 25
Sepsis 23 23
Reaction 22 22
Skin Inflammation 22 22
Tissue Damage 19 19
Low Blood Pressure/ Hypotension 19 19
Abscess 17 17
Chemical Exposure 16 16
Itching Sensation 15 15
Perforation of Vessels 13 13
Patient Problem/Medical Problem 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Skin Inflammation/ Irritation 12 12
Rash 12 12
Air Embolism 12 12
Edema 12 12
Cardiac Arrest 10 10
Necrosis 10 10
Skin Irritation 10 10
Rupture 10 10
Chills 9 9
Complaint, Ill-Defined 9 9
Skin Discoloration 9 9
Vessel Or Plaque, Device Embedded In 9 9
Cellulitis 9 9
Laceration(s) 8 8
Local Reaction 8 8
Numbness 8 8
Reaction, Injection Site 7 7
Pneumothorax 7 7
Nausea 7 8
Tachycardia 7 7
Pneumonia 6 6
Burning Sensation 6 6
Respiratory Distress 6 6
Distress 6 6
Venipuncture 6 6
Hemostasis 6 6
High Blood Pressure/ Hypertension 6 6
Radiation Exposure, Unintended 6 6
Unintended Radiation Exposure 5 5
Underdose 5 5
Fatigue 5 5
Feeding Problem 5 5
Hepatitis 5 5
Dyspnea 5 6
Loss of consciousness 5 5
Vomiting 5 5
Weakness 5 5
Staphylococcus Aureus 4 4
Perforation 4 4
Skin Tears 4 4
Anxiety 4 4
Emotional Changes 4 4
Stroke/CVA 4 4
Hyperemia 4 4
Tissue Breakdown 4 4
Alteration In Body Temperature 4 4
Fluid Discharge 4 4
Not Applicable 3 3
Failure of Implant 3 3
Infarction, Cerebral 3 3
Diarrhea 3 3
Abdominal Pain 3 3
Bronchitis 3 3
Therapeutic Response, Decreased 3 3
Ulcer 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
2 Angiodynamics, Inc. II Jun-17-2020
3 Arrow International Inc II Feb-10-2021
4 Arrow International Inc II Jan-22-2020
5 Arrow International Inc II Oct-24-2019
6 Arrow International Inc II Oct-07-2019
7 Arrow International Inc II Nov-14-2018
8 Arrow International Inc II Oct-26-2018
9 Arrow International Inc II Aug-22-2018
10 Arrow International Inc II Aug-14-2018
11 Arrow International Inc II May-30-2018
12 Arrow International Inc II Apr-10-2018
13 Arrow International Inc II Mar-21-2018
14 Arrow International Inc II Mar-14-2018
15 Arrow International Inc II Mar-14-2018
16 Arrow International Inc II Mar-05-2018
17 Arrow International Inc II Feb-20-2018
18 Arrow International Inc II Jun-12-2017
19 Arrow International Inc II Jun-06-2017
20 Arrow International Inc II Apr-10-2017
21 Becton Dickinson & Company II Oct-19-2020
22 Becton Dickinson & Company II Jun-03-2019
23 Becton Dickinson & Company II Nov-04-2018
24 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
25 Braxton Medical Corporation II Jan-27-2021
26 Cook Inc. II Mar-24-2020
27 Cook Inc. II Feb-15-2018
28 Delta Med SpA II Aug-16-2021
29 Janus Trade Group II Nov-30-2020
30 Smiths Medical ASD Inc. II Nov-08-2019
31 Smiths Medical ASD Inc. II Apr-25-2019
32 Terumo Medical Corporation II May-01-2017
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