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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 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Break 24 24
Connection Problem 23 23
Material Fragmentation 19 19
Problem with Sterilization 19 19
Tear, Rip or Hole in Device Packaging 19 19
Fluid/Blood Leak 18 18
Leak/Splash 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Material Integrity Problem 12 12
Material Frayed 12 12
Appropriate Term/Code Not Available 11 11
Device Contamination with Chemical or Other Material 10 10
Crack 10 10
Disconnection 10 10
Material Separation 10 10
Unsealed Device Packaging 8 8
Contamination /Decontamination Problem 8 8
Component Missing 7 7
Device Reprocessing Problem 7 7
Contamination 7 7
Material Puncture/Hole 6 6
Detachment of Device or Device Component 6 6
Packaging Problem 6 6
Air/Gas in Device 6 6
Incomplete or Inadequate Connection 5 5
Device Handling Problem 4 4
Improper Flow or Infusion 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
Blocked Connection 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 154 154
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 31 31
Insufficient Information 29 29
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
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
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
Speech Disorder 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 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 Jun-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
10 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
16 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
17 Medline Industries Inc II Dec-10-2021
18 Medline Industries Inc II Jan-07-2021
19 ROi CPS LLC II Nov-16-2023
20 ROi CPS LLC II Nov-23-2022
21 ROi CPS LLC II Jul-19-2022
22 ROi CPS LLC II Jun-28-2022
23 ROi CPS LLC II May-09-2022
24 ROi CPS LLC II Apr-08-2021
25 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
26 Terumo Cardiovascular Systems Corp II Apr-18-2022
27 Terumo Cardiovascular Systems Corporation II Mar-29-2024
28 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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