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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
2017 3 3
2018 5 5
2019 11 11
2020 7 7
2021 7 7
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 8 8
Device Contamination with Chemical or Other Material 5 5
Leak/Splash 3 3
Contamination 2 2
Crack 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 1 1
Loss of or Failure to Bond 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Disconnection 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Device Damaged Prior to Use 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Incomplete or Missing Packaging 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
No Information 2 2
Blood Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abrasion 1 1
Laceration(s) 1 1
Pain 1 1
Discomfort 1 1
Needle Stick/Puncture 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Feb-28-2018
2 Busse Hospital Disposables, Inc. II May-28-2022
3 Centurion Medical Products Corporation II Oct-09-2019
4 Centurion Medical Products Corporation II Aug-06-2019
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 ROi CPS LLC II Apr-26-2022
7 ROi CPS LLC III Mar-30-2022
8 Resource Optimization & Innovation LLC II Apr-18-2022
9 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-09-2018
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