TPLC - Total Product Life Cycle

show TPLC since

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 Code	LRS
Regulation Number	880.5200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	11	11
Break	10	10
Detachment of Device or Device Component	7	7
Component Missing	6	6
Appropriate Term/Code Not Available	5	5
Crack	4	4
Material Integrity Problem	4	4
Material Split, Cut or Torn	3	3
Physical Resistance/Sticking	3	3
Defective Device	3	3
Infusion or Flow Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Packaging Problem	3	3
Fluid/Blood Leak	2	2
Loss of or Failure to Bond	2	2
Device Markings/Labelling Problem	2	2
Connection Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Contamination	2	3
Sharp Edges	2	2
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Component Incompatible	1	1
Protective Measures Problem	1	1
Migration	1	1
Activation Failure	1	1
Device Contamination with Chemical or Other Material	1	1
Inadequacy of Device Shape and/or Size	1	1
Delivered as Unsterile Product	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
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Defective Component	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Device Damaged Prior to Use	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	54	55
Insufficient Information	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Needle Stick/Puncture	4	4
Hemorrhage/Bleeding	3	3
Burn(s)	2	2
Pain	2	2
Unspecified Tissue Injury	2	2
Infiltration into Tissue	2	2
Hypersensitivity/Allergic reaction	1	1
Abrasion	1	1
No Known Impact Or Consequence To Patient	1	1
Dyspnea	1	1
Tachycardia	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	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	ROi CPS LLC	II	Apr-26-2022
17	ROi CPS LLC	III	Mar-30-2022
18	Resource Optimization & Innovation LLC	II	Apr-18-2022
19	Stradis Healthcare	II	Jan-11-2023