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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
Regulation Description Intravascular catheter.
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 2
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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
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 4660 4660

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5730 5730
Device Contamination with Chemical or Other Material 2337 2337
Break 2082 2082
Retraction Problem 1090 1090
Fluid Leak 924 924
Material Deformation 531 531
Material Separation 492 492
Adverse Event Without Identified Device or Use Problem 485 485
Material Protrusion/Extrusion 445 445
Crack 327 327
Detachment of Device or Device Component 290 290
Deformation Due to Compressive Stress 280 280
Unraveled Material 275 275
Packaging Problem 239 239
Device Operates Differently Than Expected 231 231
Difficult to Remove 196 196
Difficult or Delayed Activation 194 194
Physical Resistance/Sticking 193 193
Difficult to Advance 168 168
Material Puncture/Hole 166 166
Dull, Blunt 163 163
Detachment Of Device Component 159 159
Kinked 158 158
Device Markings/Labelling Problem 150 150
Material Split, Cut or Torn 143 143
Unsealed Device Packaging 133 133
Component Missing 132 132
Material Twisted/Bent 132 132
Defective Component 129 129
Fracture 129 129
Failure to Advance 128 128
Complete Blockage 127 127
Material Frayed 124 124
Device Damaged Prior to Use 121 121
Contamination /Decontamination Problem 121 121
Difficult to Insert 118 118
Material Integrity Problem 111 111
Material Fragmentation 109 109
Obstruction of Flow 103 103
Delivered as Unsterile Product 96 96
Protective Measures Problem 95 95
Bent 84 84
Fail-Safe Problem 83 83
Activation Problem 83 83
Insufficient Information 81 81
Loose or Intermittent Connection 81 81
Defective Device 80 80
Product Quality Problem 80 80
Material Rupture 80 80
Entrapment of Device 77 77
Infusion or Flow Problem 77 77
Disconnection 72 72
Nonstandard Device 67 67
Sticking 67 67
Physical Resistance 65 65
Hole In Material 63 63
Microbial Contamination of Device 59 59
Structural Problem 58 58
Improper or Incorrect Procedure or Method 56 56
Patient-Device Incompatibility 53 53
Occlusion Within Device 46 46
Mechanical Problem 45 45
Appropriate Term/Code Not Available 44 44
Device Dislodged or Dislocated 43 43
Gas Leak 43 43
Use of Device Problem 43 43
Difficult To Position 42 42
Activation, Positioning or SeparationProblem 41 41
Fail-Safe Did Not Operate 40 40
Difficult or Delayed Positioning 40 40
Failure to Deliver 39 39
Device Packaging Compromised 36 36
Fitting Problem 35 35
Material Discolored 35 35
Tear, Rip or Hole in Device Packaging 34 34
Free or Unrestricted Flow 34 34
Manufacturing, Packaging or Shipping Problem 33 33
Material Perforation 32 32
Fail-Safe Design Failure 30 30
Connection Problem 30 30
Improper Flow or Infusion 29 29
Positioning Problem 26 26
Contamination 26 26
Flushing Problem 26 26
Split 26 26
Partial Blockage 25 25
Problem with Sterilization 24 24
Difficult to Flush 23 23
Migration or Expulsion of Device 23 23
Device Fell 21 21
Therapeutic or Diagnostic Output Failure 20 20
Device Slipped 20 20
Backflow 19 19
Degraded 19 19
Malposition of Device 19 19
Illegible Information 19 19
Burst Container or Vessel 18 18
Component Falling 17 17
Peeled/Delaminated 17 17
Device Disinfection Or Sterilization Issue 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6767 6767
No Consequences Or Impact To Patient 3763 3763
No Clinical Signs, Symptoms or Conditions 3639 3639
No Patient Involvement 659 659
No Information 472 472
Foreign Body In Patient 455 455
No Code Available 344 344
Needle Stick/Puncture 317 317
Insufficient Information 313 313
Pain 274 274
Device Embedded In Tissue or Plaque 258 258
Blood Loss 174 174
Bacterial Infection 163 163
Exposure to Body Fluids 145 145
Unspecified Infection 108 108
Hypersensitivity/Allergic reaction 93 93
Extravasation 88 88
Swelling 86 86
Hemorrhage/Bleeding 76 76
Phlebitis 68 68
Infiltration into Tissue 61 61
Erythema 52 52
Death 46 46
Injury 46 46
Hematoma 43 43
Discomfort 40 40
Inflammation 37 37
Bruise/Contusion 37 37
Fever 33 33
Thrombus 27 27
Thrombosis 26 26
Anaphylactic Shock 26 26
Thrombosis/Thrombus 25 25
Sepsis 23 23
Reaction 22 22
Skin Inflammation 22 22
Tissue Damage 19 19
Low Blood Pressure/ Hypotension 18 18
Abscess 17 17
Chemical Exposure 16 16
Swelling/ Edema 16 16
Itching Sensation 15 15
Patient Problem/Medical Problem 13 13
Air Embolism 12 12
Edema 12 12
Cardiac Arrest 10 10
Skin Irritation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Skin Discoloration 9 9
Rash 9 9
Complaint, Ill-Defined 9 9
Chills 9 9
Vessel Or Plaque, Device Embedded In 9 9
Cellulitis 9 9
Necrosis 9 9
Numbness 8 8
Local Reaction 8 8
Reaction, Injection Site 7 7
Rupture 7 7
Nausea 7 8
Laceration(s) 7 7
Hemostasis 6 6
Distress 6 6
Respiratory Distress 6 6
Pneumonia 6 6
Pneumothorax 6 6
Burning Sensation 6 6
Venipuncture 6 6
Radiation Exposure, Unintended 6 6
Skin Inflammation/ Irritation 5 5
Perforation of Vessels 5 5
Vomiting 5 5
Weakness 5 5
Tachycardia 5 5
Underdose 5 5
Loss of consciousness 5 5
Hepatitis 5 5
High Blood Pressure/ Hypertension 5 5
Feeding Problem 5 5
Dyspnea 5 6
Emotional Changes 4 4
Stroke/CVA 4 4
Fatigue 4 4
Hyperemia 4 4
Staphylococcus Aureus 4 4
Perforation 4 4
Unintended Radiation Exposure 4 4
Alteration In Body Temperature 4 4
Fluid Discharge 4 4
Skin Tears 4 4
Tissue Breakdown 3 3
Not Applicable 3 3
Pleural Effusion 3 3
Chest Tightness/Pressure 3 3
Therapeutic Response, Decreased 3 3
Ulcer 3 3
Pressure Sores 3 3
Anxiety 3 3
Failure of Implant 3 3
Infarction, Cerebral 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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