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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiac catheterization kit
Regulation Description Diagnostic intravascular catheter.
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 CodeOES
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2020 35 35
2021 21 21
2022 13 13
2023 18 18
2024 113 113
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 25 25
Connection Problem 24 24
Appropriate Term/Code Not Available 22 22
Break 20 20
Crack 20 20
Leak/Splash 9 9
Unraveled Material 7 7
Material Fragmentation 7 7
Material Frayed 6 6
Physical Resistance/Sticking 6 6
Failure to Advance 6 6
Fluid/Blood Leak 5 5
Material Deformation 5 5
Contamination /Decontamination Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Packaging Problem 4 4
Material Separation 4 4
Contamination 4 4
Difficult to Insert 3 3
Component Missing 3 3
Obstruction of Flow 3 3
Material Puncture/Hole 3 3
Activation, Positioning or Separation Problem 3 3
Material Split, Cut or Torn 3 3
Air/Gas in Device 2 2
Device Markings/Labelling Problem 2 2
Stretched 2 2
Difficult to Advance 2 2
Insufficient Information 2 2
Deformation Due to Compressive Stress 2 2
Retraction Problem 2 2
Detachment of Device or Device Component 2 2
Incomplete or Missing Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Peeled/Delaminated 1 1
Device Dislodged or Dislocated 1 1
Difficult to Remove 1 1
Difficult or Delayed Positioning 1 1
Unexpected Therapeutic Results 1 1
Degraded 1 1
Mechanical Jam 1 1
Particulates 1 1
Fitting Problem 1 1
Melted 1 1
Burst Container or Vessel 1 1
Improper Flow or Infusion 1 1
Defective Component 1 1
Defective Device 1 1
Gas/Air Leak 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 130 130
Insufficient Information 28 28
No Consequences Or Impact To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 3 3
Low Blood Pressure/ Hypotension 3 3
Hemorrhage/Bleeding 3 3
Exposure to Body Fluids 2 2
Abrasion 1 1
Air Embolism 1 1
Obstruction/Occlusion 1 1
Unspecified Kidney or Urinary Problem 1 1
Patient Problem/Medical Problem 1 1
Needle Stick/Puncture 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Nov-14-2024
2 American Contract Systems II May-29-2020
3 American Contract Systems, Inc. II Sep-24-2024
4 American Contract Systems, Inc. II Jan-26-2024
5 American Contract Systems, Inc. II Oct-26-2023
6 American Contract Systems, Inc. II Sep-08-2022
7 American Contract Systems, Inc. II May-06-2022
8 Avid Medical, Inc. II Mar-19-2020
9 Cardinal Health 200, LLC II Jul-10-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
16 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
18 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
23 ROi CPS LLC II Apr-25-2023
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