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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device i.v. start kit
Regulation Description 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeLRS
Regulation Number 880.5200
Device Class 2

MDR Year MDR Reports MDR Events
2021 7 7
2022 7 7
2023 34 34
2024 20 20
2025 34 34
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 11 11
Break 11 11
Defective Device 7 7
Appropriate Term/Code Not Available 7 7
Detachment of Device or Device Component 7 7
Component Missing 7 7
Material Integrity Problem 6 6
Crack 4 4
Product Quality Problem 4 4
Fluid/Blood Leak 3 3
Packaging Problem 3 3
Infusion or Flow Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loss of or Failure to Bond 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Device Markings/Labelling Problem 2 2
Connection Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Sharp Edges 2 2
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Component Incompatible 1 1
Device Dislodged or Dislocated 1 1
Migration 1 1
Activation Failure 1 1
Lack of Effect 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Patient Device Interaction Problem 1 1
Contamination 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Patient-Device Incompatibility 1 1
Separation Failure 1 1
Migration or Expulsion of Device 1 1
Pressure Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Needle Stick/Puncture 4 4
Abrasion 3 3
Hemorrhage/Bleeding 3 3
Burn(s) 2 2
Infiltration into Tissue 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Contact Dermatitis 1 1
Tachycardia 1 1
Laceration(s) 1 1
Dyspnea 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. II May-28-2022
2 Cardinal Health 200, LLC II Feb-22-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Jun-30-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
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-06-2023
14 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
15 Medical Action Industries, Inc. 306 II Mar-28-2024
16 Medline Industries, LP II Feb-17-2026
17 Medline Industries, LP II Jan-12-2026
18 ROi CPS LLC II Apr-26-2022
19 ROi CPS LLC III Mar-30-2022
20 Resource Optimization & Innovation LLC II Apr-18-2022
21 Stradis Healthcare II Jan-11-2023
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