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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
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
2019 71 71
2020 65 65
2021 42 42
2022 36 36
2023 24 24
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 41 41
Break 25 25
Appropriate Term/Code Not Available 21 21
Leak/Splash 20 20
Fluid/Blood Leak 19 19
Tear, Rip or Hole in Device Packaging 19 19
Problem with Sterilization 19 19
Material Fragmentation 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Material Integrity Problem 13 13
Material Frayed 12 12
Disconnection 10 10
Device Contamination with Chemical or Other Material 10 10
Crack 10 10
Material Separation 10 10
Unsealed Device Packaging 9 9
Contamination /Decontamination Problem 8 8
Device Reprocessing Problem 7 7
Contamination 7 7
Component Missing 7 7
Detachment of Device or Device Component 6 6
Material Puncture/Hole 6 6
Packaging Problem 6 6
Air/Gas in Device 6 6
Incomplete or Inadequate Connection 5 5
Insufficient Information 4 4
Device Handling Problem 4 4
Improper Flow or Infusion 4 4
Material Rupture 3 3
Delivered as Unsterile Product 3 3
Mechanical Problem 3 3
Degraded 2 2
Use of Device Problem 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Component Misassembled 2 2
Fracture 2 2
Device Contaminated During Manufacture or Shipping 2 2
Human-Device Interface Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Gas/Air Leak 1 1
Difficult to Remove 1 1
Deflation Problem 1 1
Blocked Connection 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 186 186
No Known Impact Or Consequence To Patient 46 46
Insufficient Information 35 35
No Patient Involvement 31 31
Air Embolism 18 18
Foreign Body In Patient 15 15
No Consequences Or Impact To Patient 15 15
Blood Loss 14 14
Not Applicable 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 3 3
Hemolysis 3 3
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Exposure to Body Fluids 2 2
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
Arrhythmia 1 1
Speech Disorder 1 1
Skin Inflammation/ Irritation 1 1
Ischemia 1 1
Perforation 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Hepatitis 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 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 Jul-10-2024
9 Cardinal Health 200, LLC II Oct-10-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
19 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
20 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
26 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
27 Medline Industries Inc II Dec-10-2021
28 Medline Industries Inc II Jan-07-2021
29 Merit Medical Systems, Inc. II Aug-12-2024
30 ROi CPS LLC II Nov-16-2023
31 ROi CPS LLC II Nov-23-2022
32 ROi CPS LLC II Jul-19-2022
33 ROi CPS LLC II Jun-28-2022
34 ROi CPS LLC II May-09-2022
35 ROi CPS LLC II Apr-08-2021
36 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
37 Terumo Cardiovascular Systems Corp II Apr-18-2022
38 Terumo Cardiovascular Systems Corporation II Mar-29-2024
39 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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