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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 58 58
Break 26 26
Appropriate Term/Code Not Available 23 23
Material Fragmentation 19 19
Fluid/Blood Leak 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Leak/Splash 16 16
Material Integrity Problem 14 14
Material Frayed 12 12
Crack 12 12
Material Separation 10 10
Unsealed Device Packaging 7 7
Device Contamination with Chemical or Other Material 7 7
Contamination 7 7
Contamination /Decontamination Problem 7 7
Component Missing 7 7
Disconnection 6 6
Insufficient Information 6 6
Air/Gas in Device 6 6
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
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Packaging Problem 3 3
Delivered as Unsterile Product 3 3
Problem with Sterilization 3 3
Loss of or Failure to Bond 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Human-Device Interface Problem 2 2
Component Misassembled 2 2
Infusion or Flow Problem 2 2
Improper Flow or Infusion 2 2
Use of Device Problem 2 2
Degraded 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Difficult or Delayed Activation 1 1
Gas/Air Leak 1 1
Dent in Material 1 1
Obstruction of Flow 1 1
Blocked Connection 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Rupture 1 1
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 217 217
Insufficient Information 44 44
No Known Impact Or Consequence To Patient 20 20
Foreign Body In Patient 17 17
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
Hemolysis 3 3
No Patient Involvement 3 3
Laceration(s) 3 3
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Exposure to Body Fluids 2 2
Hemorrhage/Bleeding 2 2
Arrhythmia 1 1
Death 1 1
Speech Disorder 1 1
Skin Inflammation/ Irritation 1 1
Perforation 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Needle Stick/Puncture 1 1
Thrombosis/Thrombus 1 1
Visual Impairment 1 1
Therapeutic Response, Decreased 1 1
Low Blood Pressure/ Hypotension 1 1
Ischemia Stroke 1 1

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