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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
2020 7 7
2021 7 7
2022 7 7
2023 34 34
2024 20 20
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 9 9
Detachment of Device or Device Component 7 7
Break 6 6
Component Missing 6 6
Crack 4 4
Material Integrity Problem 4 4
Physical Resistance/Sticking 3 3
Packaging Problem 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Contamination 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Sharp Edges 2 2
Connection Problem 2 2
Fluid/Blood Leak 2 2
Disconnection 1 1
Migration or Expulsion of Device 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Difficult to Insert 1 1
Material Twisted/Bent 1 1
Infusion or Flow Problem 1 1
Lack of Effect 1 1
Delivered as Unsterile Product 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Contamination with Chemical or Other Material 1 1
Migration 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
Insufficient Information 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Needle Stick/Puncture 4 4
Pain 2 2
Unspecified Tissue Injury 2 2
Hemorrhage/Bleeding 2 2
Infiltration into Tissue 2 2
Hypersensitivity/Allergic reaction 1 1
Abrasion 1 1
No Known Impact Or Consequence To Patient 1 1
Contact Dermatitis 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 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 Apr-17-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
8 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
12 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
13 Medical Action Industries, Inc. 306 II Mar-28-2024
14 ROi CPS LLC II Apr-26-2022
15 ROi CPS LLC III Mar-30-2022
16 Resource Optimization & Innovation LLC II Apr-18-2022
17 Stradis Healthcare II Jan-11-2023
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