• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 8 8
Detachment of Device or Device Component 7 7
Break 5 5
Leak/Splash 4 4
Device Contamination with Chemical or Other Material 3 3
Packaging Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Sharp Edges 2 2
Material Split, Cut or Torn 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Contamination 2 2
Crack 2 2
Disconnection 2 2
Fluid/Blood Leak 2 2
Difficult to Insert 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Device Markings/Labelling Problem 1 1
Connection Problem 1 1
Loss of or Failure to Bond 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 3 3
Needle Stick/Puncture 2 2
Infiltration into Tissue 2 2
Pain 2 2
Abrasion 1 1
Laceration(s) 1 1
Skin Tears 1 1
Blood Loss 1 1
Unspecified Tissue Injury 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 I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
10 ROi CPS LLC II Apr-26-2022
11 ROi CPS LLC III Mar-30-2022
12 Resource Optimization & Innovation LLC II Apr-18-2022
13 Stradis Healthcare II Jan-11-2023
-
-