• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Problem with Sterilization 19 19
Tear, Rip or Hole in Device Packaging 19 19
Material Fragmentation 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Break 16 16
Material Frayed 12 12
Leak/Splash 10 10
Fluid/Blood Leak 10 10
Disconnection 10 10
Device Contamination with Chemical or Other Material 10 10
Material Separation 9 9
Contamination /Decontamination Problem 8 8
Unsealed Device Packaging 8 8
Device Reprocessing Problem 7 7
Crack 6 6
Material Puncture/Hole 6 6
Component Missing 6 6
Packaging Problem 6 6
Air/Gas in Device 6 6
Appropriate Term/Code Not Available 5 5
Device Handling Problem 4 4
Improper Flow or Infusion 4 4
Material Integrity Problem 4 4
Incomplete or Inadequate Connection 4 4
Insufficient Information 3 3
Material Rupture 3 3
Contamination 3 3
Delivered as Unsterile Product 3 3
Degraded 2 2
Fracture 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Separation Problem 1 1
Suction Problem 1 1
Defective Component 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Self-Activation or Keying 1 1
Connection Problem 1 1
Difficult or Delayed Activation 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Circuit Failure 1 1
Deflation Problem 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 31 31
Insufficient Information 21 21
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
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
Hepatitis 1 1
Low Blood Pressure/ Hypotension 1 1
Ischemia 1 1
Laceration(s) 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Speech Disorder 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Feb-27-2019
-
-