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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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Break 22 22
Material Fragmentation 19 19
Problem with Sterilization 19 19
Tear, Rip or Hole in Device Packaging 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Fluid/Blood Leak 13 13
Material Frayed 12 12
Leak/Splash 12 12
Crack 10 10
Disconnection 10 10
Material Separation 10 10
Device Contamination with Chemical or Other Material 10 10
Contamination /Decontamination Problem 8 8
Unsealed Device Packaging 8 8
Component Missing 7 7
Device Reprocessing Problem 7 7
Material Integrity Problem 7 7
Appropriate Term/Code Not Available 7 7
Air/Gas in Device 6 6
Packaging Problem 6 6
Contamination 6 6
Material Puncture/Hole 6 6
Connection Problem 4 4
Detachment of Device or Device Component 4 4
Improper Flow or Infusion 4 4
Device Handling Problem 4 4
Incomplete or Inadequate Connection 4 4
Insufficient Information 3 3
Material Rupture 3 3
Mechanical Problem 3 3
Delivered as Unsterile Product 3 3
Fracture 2 2
Degraded 2 2
Defective Device 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
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Infusion or Flow Problem 1 1
Gas/Air Leak 1 1
Device Dislodged or Dislocated 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Separation Problem 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Suction Problem 1 1
Defective Component 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Self-Activation or Keying 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Loose or Intermittent Connection 1 1
Circuit Failure 1 1
Material Disintegration 1 1
Deflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 31 31
Insufficient Information 24 24
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
Death 3 3
Hemolysis 3 3
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Speech Disorder 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 1 1
Perforation 1 1
Visual Impairment 1 1
Therapeutic Response, Decreased 1 1
Needle Stick/Puncture 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Arrhythmia 1 1
Hepatitis 1 1
Low Blood Pressure/ Hypotension 1 1
Ischemia 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 Oct-10-2023
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
13 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
14 Medline Industries Inc II Dec-10-2021
15 Medline Industries Inc II Jan-07-2021
16 ROi CPS LLC II Nov-16-2023
17 ROi CPS LLC II Nov-23-2022
18 ROi CPS LLC II Jul-19-2022
19 ROi CPS LLC II Jun-28-2022
20 ROi CPS LLC II May-09-2022
21 ROi CPS LLC II Apr-08-2021
22 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
23 Terumo Cardiovascular Systems Corp II Apr-18-2022
24 Terumo Cardiovascular Systems Corporation II Mar-29-2024
25 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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