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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 3
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
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1964 1964
2018 3295 3295
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 2672 2672

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6202 6202
Device Contamination with Chemical or Other Material 2457 2457
Break 2396 2396
Retraction Problem 1255 1255
Fluid Leak 1049 1049
Material Separation 646 646
Material Deformation 607 607
Adverse Event Without Identified Device or Use Problem 512 512
Deformation Due to Compressive Stress 482 482
Material Protrusion/Extrusion 481 481
Crack 393 393
Detachment of Device or Device Component 368 368
Unraveled Material 326 326
Material Puncture/Hole 289 289
Defective Component 265 265
Packaging Problem 265 265
Physical Resistance/Sticking 252 252
Material Split, Cut or Torn 234 234
Device Operates Differently Than Expected 231 231
Difficult to Remove 231 231
Difficult or Delayed Activation 206 206
Material Twisted/Bent 195 195
Difficult to Advance 189 189
Dull, Blunt 175 175
Material Frayed 169 169
Device Markings/Labelling Problem 162 162
Detachment Of Device Component 159 159
Kinked 158 158
Fracture 156 156
Component Missing 155 155
Difficult to Insert 144 144
Defective Device 142 142
Unsealed Device Packaging 141 141
Failure to Advance 137 137
Complete Blockage 133 133
Device Damaged Prior to Use 128 128
Obstruction of Flow 125 125
Contamination /Decontamination Problem 124 124
Material Integrity Problem 116 116
Material Fragmentation 112 112
Fail-Safe Problem 108 108
Activation Problem 104 104
Delivered as Unsterile Product 104 104
Loose or Intermittent Connection 101 101
Protective Measures Problem 96 96
Material Rupture 93 93
Product Quality Problem 86 86
Entrapment of Device 85 85
Bent 84 84
Insufficient Information 84 84
Infusion or Flow Problem 81 81
Disconnection 78 78
Improper or Incorrect Procedure or Method 73 73
Sticking 67 67
Nonstandard Device 67 67
Contamination 66 66
Physical Resistance 65 65
Hole In Material 63 63
Material Perforation 62 62
Microbial Contamination of Device 59 59
Structural Problem 59 59
Mechanical Problem 56 56
Patient-Device Incompatibility 54 54
Fitting Problem 51 51
Use of Device Problem 48 48
Appropriate Term/Code Not Available 47 47
Fail-Safe Did Not Operate 46 46
Device Dislodged or Dislocated 46 46
Occlusion Within Device 46 46
Activation, Positioning or SeparationProblem 45 45
Gas Leak 45 45
Difficult To Position 42 42
Failure to Deliver 41 41
Difficult or Delayed Positioning 41 41
Tear, Rip or Hole in Device Packaging 40 40
Material Discolored 39 39
Free or Unrestricted Flow 37 37
Device Packaging Compromised 36 36
Manufacturing, Packaging or Shipping Problem 33 33
Improper Flow or Infusion 32 32
Connection Problem 31 31
Separation Problem 31 31
Fail-Safe Design Failure 30 30
Positioning Problem 29 29
Migration or Expulsion of Device 28 28
Flushing Problem 27 27
Difficult to Flush 26 26
Split 26 26
Partial Blockage 25 25
Output Problem 25 25
Problem with Sterilization 24 24
Stretched 23 23
Burst Container or Vessel 23 23
Backflow 22 22
Device Fell 22 22
Illegible Information 22 22
Device Slipped 21 21
Degraded 20 20
Therapeutic or Diagnostic Output Failure 20 20
Missing Information 19 19

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 5813 5813
No Consequences Or Impact To Patient 3763 3763
No Patient Involvement 659 659
Foreign Body In Patient 591 591
No Information 472 472
Insufficient Information 450 450
Needle Stick/Puncture 347 347
No Code Available 344 344
Pain 328 328
Device Embedded In Tissue or Plaque 271 271
Blood Loss 174 174
Bacterial Infection 167 167
Exposure to Body Fluids 151 151
Extravasation 116 116
Unspecified Infection 113 113
Hemorrhage/Bleeding 109 109
Hypersensitivity/Allergic reaction 97 97
Swelling 86 86
Phlebitis 85 85
Infiltration into Tissue 68 68
Erythema 63 63
Hematoma 57 57
Death 46 46
Injury 46 46
Bruise/Contusion 43 43
Discomfort 42 42
Inflammation 41 41
Fever 34 34
Thrombosis/Thrombus 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Swelling/ Edema 27 27
Thrombus 27 27
Thrombosis 26 26
Anaphylactic Shock 26 26
Sepsis 23 23
Reaction 22 22
Skin Inflammation 22 22
Low Blood Pressure/ Hypotension 20 20
Tissue Damage 19 19
Perforation of Vessels 18 18
Abscess 18 18
Chemical Exposure 16 16
Itching Sensation 15 15
Skin Discoloration 14 14
Patient Problem/Medical Problem 13 13
Skin Inflammation/ Irritation 12 12
Rash 12 12
Air Embolism 12 12
Edema 12 12
Rupture 11 11
Skin Irritation 10 10
Cardiac Arrest 10 10
Necrosis 10 10
Laceration(s) 9 9
Vessel Or Plaque, Device Embedded In 9 9
Cellulitis 9 9
Chills 9 9
Complaint, Ill-Defined 9 9
Numbness 8 8
Local Reaction 8 8
Abrasion 8 8
Nausea 7 8
Tachycardia 7 7
Pneumothorax 7 7
Reaction, Injection Site 7 7
Distress 7 7
Burning Sensation 6 6
Venipuncture 6 6
Pneumonia 6 6
Respiratory Distress 6 6
Hemostasis 6 6
High Blood Pressure/ Hypertension 6 6
Radiation Exposure, Unintended 6 6
Underdose 5 5
Unintended Radiation Exposure 5 5
Fatigue 5 5
Feeding Problem 5 5
Hepatitis 5 5
Dyspnea 5 6
Perforation 5 5
Vomiting 5 5
Weakness 5 5
Loss of consciousness 5 5
Anxiety 4 4
Staphylococcus Aureus 4 4
Emotional Changes 4 4
Stroke/CVA 4 4
Hyperemia 4 4
Failure of Implant 4 4
Skin Tears 4 4
Tissue Breakdown 4 4
Alteration In Body Temperature 4 4
Fluid Discharge 4 4
Not Applicable 3 3
Hypoxia 3 3
Infarction, Cerebral 3 3
Diarrhea 3 3
Abdominal Pain 3 3
Bronchitis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Jun-27-2022
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
3 Angiodynamics, Inc. II Jun-17-2020
4 Arrow International Inc II Feb-10-2021
5 Arrow International Inc II Jan-22-2020
6 Arrow International Inc II Oct-24-2019
7 Arrow International Inc II Oct-07-2019
8 Arrow International Inc II Nov-14-2018
9 Arrow International Inc II Oct-26-2018
10 Arrow International Inc II Aug-22-2018
11 Arrow International Inc II Aug-14-2018
12 Arrow International Inc II May-30-2018
13 Arrow International Inc II Apr-10-2018
14 Arrow International Inc II Mar-21-2018
15 Arrow International Inc II Mar-14-2018
16 Arrow International Inc II Mar-14-2018
17 Arrow International Inc II Mar-05-2018
18 Arrow International Inc II Feb-20-2018
19 Arrow International Inc II Jun-12-2017
20 Arrow International Inc II Jun-06-2017
21 Arrow International Inc II Apr-10-2017
22 Becton Dickinson & Company II Oct-19-2020
23 Becton Dickinson & Company II Jun-03-2019
24 Becton Dickinson & Company II Nov-04-2018
25 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
26 Braxton Medical Corporation II Jan-27-2021
27 Cook Inc. II Mar-24-2020
28 Cook Inc. II Feb-15-2018
29 Delta Med SpA II Aug-16-2021
30 Janus Trade Group II Nov-30-2020
31 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
32 Smiths Medical ASD Inc. II Nov-08-2019
33 Smiths Medical ASD Inc. II Apr-25-2019
34 Terumo Medical Corporation II May-01-2017
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