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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device cardiovascular procedure kit
Regulation Description Diagnostic intravascular catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEZ
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2020 65 65
2021 42 42
2022 36 36
2023 24 24
2024 147 147
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 51 51
Break 25 25
Appropriate Term/Code Not Available 21 21
Material Fragmentation 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Leak/Splash 16 16
Fluid/Blood Leak 15 15
Material Integrity Problem 14 14
Material Frayed 12 12
Crack 12 12
Material Separation 10 10
Contamination /Decontamination Problem 7 7
Device Contamination with Chemical or Other Material 7 7
Component Missing 7 7
Unsealed Device Packaging 7 7
Disconnection 6 6
Contamination 6 6
Air/Gas in Device 6 6
Insufficient Information 5 5
Incomplete or Inadequate Connection 5 5
Tear, Rip or Hole in Device Packaging 5 5
Detachment of Device or Device Component 4 4
Device Handling Problem 4 4
Delivered as Unsterile Product 3 3
Problem with Sterilization 3 3
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Packaging Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Infusion or Flow Problem 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Component Misassembled 2 2
Human-Device Interface Problem 2 2
Defective Device 2 2
Degraded 2 2
Improper Flow or Infusion 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Self-Activation or Keying 1 1
Fracture 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 1 1
Loose or Intermittent Connection 1 1
Gas/Air Leak 1 1
Device Dislodged or Dislocated 1 1
Partial Blockage 1 1
Positioning Problem 1 1
Material Disintegration 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 204 204
Insufficient Information 41 41
No Known Impact Or Consequence To Patient 20 20
Foreign Body In Patient 16 16
Air Embolism 16 16
No Consequences Or Impact To Patient 11 11
Blood Loss 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Patient Involvement 3 3
Hemolysis 3 3
Memory Loss/Impairment 2 2
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 2 2
Muscle Weakness 2 2
Laceration(s) 2 2
Low Blood Pressure/ Hypotension 1 1
Perforation 1 1
Visual Impairment 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Needle Stick/Puncture 1 1
Skin Inflammation/ Irritation 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Arrhythmia 1 1
Speech Disorder 1 1
Therapeutic Response, Decreased 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Nov-14-2024
2 American Contract Systems, Inc. II Sep-24-2024
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Oct-26-2023
5 American Contract Systems, Inc. II Sep-08-2022
6 Avid Medical, Inc. I Jun-04-2021
7 Avid Medical, Inc. II Mar-19-2020
8 Cardinal Health 200, LLC II Feb-10-2025
9 Cardinal Health 200, LLC II Jan-15-2025
10 Cardinal Health 200, LLC II Jul-10-2024
11 Cardinal Health 200, LLC II Oct-10-2023
12 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
25 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
26 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
28 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
29 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
30 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
31 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
32 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
33 Medline Industries Inc II Dec-10-2021
34 Medline Industries Inc II Jan-07-2021
35 Merit Medical Systems, Inc. II Aug-12-2024
36 ROi CPS LLC II Nov-16-2023
37 ROi CPS LLC II Nov-23-2022
38 ROi CPS LLC II Jul-19-2022
39 ROi CPS LLC II Jun-28-2022
40 ROi CPS LLC II May-09-2022
41 ROi CPS LLC II Apr-08-2021
42 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
43 Terumo Cardiovascular Systems Corp II Apr-18-2022
44 Terumo Cardiovascular Systems Corporation II Mar-29-2024
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