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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
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
2019 11 11
2020 7 7
2021 7 7
2022 7 7
2023 34 34
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 10 10
Component Missing 8 8
Detachment of Device or Device Component 7 7
Break 6 6
Crack 5 5
Physical Resistance/Sticking 3 3
Packaging Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Appropriate Term/Code Not Available 3 3
Disconnection 2 2
Material Split, Cut or Torn 2 2
Device Markings/Labelling Problem 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
Device Contaminated During Manufacture or Shipping 1 1
Migration or Expulsion of Device 1 1
Device Damaged Prior to Use 1 1
Insufficient Information 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity 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
Migration 1 1
Protective Measures Problem 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 41 41
Insufficient Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Known Impact Or Consequence To Patient 8 8
Needle Stick/Puncture 3 3
No Consequences Or Impact To Patient 3 3
Pain 2 2
Unspecified Tissue Injury 2 2
Infiltration into Tissue 2 2
Abrasion 1 1
Blood Loss 1 1
Laceration(s) 1 1
Skin Tears 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 Centurion Medical Products Corporation II Oct-09-2019
4 Centurion Medical Products Corporation II Aug-06-2019
5 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
14 Medical Action Industries, Inc. 306 II Mar-28-2024
15 ROi CPS LLC II Apr-26-2022
16 ROi CPS LLC III Mar-30-2022
17 Resource Optimization & Innovation LLC II Apr-18-2022
18 Stradis Healthcare II Jan-11-2023
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