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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 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 40 40
Break 25 25
Leak/Splash 20 20
Fluid/Blood Leak 19 19
Material Fragmentation 19 19
Tear, Rip or Hole in Device Packaging 19 19
Problem with Sterilization 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Appropriate Term/Code Not Available 15 15
Material Integrity Problem 12 12
Material Frayed 12 12
Material Separation 10 10
Crack 10 10
Device Contamination with Chemical or Other Material 10 10
Disconnection 10 10
Unsealed Device Packaging 8 8
Contamination /Decontamination Problem 8 8
Contamination 7 7
Component Missing 7 7
Device Reprocessing Problem 7 7
Detachment of Device or Device Component 6 6
Air/Gas in Device 6 6
Packaging Problem 6 6
Material Puncture/Hole 6 6
Incomplete or Inadequate Connection 5 5
Improper Flow or Infusion 4 4
Device Handling Problem 4 4
Delivered as Unsterile Product 3 3
Insufficient Information 3 3
Material Rupture 3 3
Mechanical Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Component Misassembled 2 2
Fracture 2 2
Use of Device Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Human-Device Interface Problem 2 2
Degraded 2 2
Defective Device 2 2
Partial Blockage 1 1
Self-Activation or Keying 1 1
Material Disintegration 1 1
Suction Problem 1 1
Unintended Movement 1 1
Loose or Intermittent Connection 1 1
Gas/Air Leak 1 1
Therapeutic or Diagnostic Output Failure 1 1
Product Quality Problem 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 179
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 31 31
Insufficient Information 31 31
Air Embolism 17 17
No Consequences Or Impact To Patient 15 15
Foreign Body In Patient 14 14
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
Muscle Weakness 2 2
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 2 2
Memory Loss/Impairment 2 2
Laceration(s) 2 2
Low Blood Pressure/ Hypotension 1 1
Ischemia 1 1
Visual Impairment 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Perforation 1 1
Skin Inflammation/ Irritation 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Hepatitis 1 1
Arrhythmia 1 1
Needle Stick/Puncture 1 1
Speech Disorder 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Oct-26-2023
3 American Contract Systems, Inc. II Sep-08-2022
4 Avid Medical, Inc. I Jun-04-2021
5 Avid Medical, Inc. II Mar-19-2020
6 Cardinal Health 200, LLC II Jul-10-2024
7 Cardinal Health 200, LLC II Oct-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
13 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
14 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
20 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
21 Medline Industries Inc II Dec-10-2021
22 Medline Industries Inc II Jan-07-2021
23 Merit Medical Systems, Inc. II Aug-12-2024
24 ROi CPS LLC II Nov-16-2023
25 ROi CPS LLC II Nov-23-2022
26 ROi CPS LLC II Jul-19-2022
27 ROi CPS LLC II Jun-28-2022
28 ROi CPS LLC II May-09-2022
29 ROi CPS LLC II Apr-08-2021
30 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
31 Terumo Cardiovascular Systems Corp II Apr-18-2022
32 Terumo Cardiovascular Systems Corporation II Mar-29-2024
33 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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