Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 peripheral catheter insertion kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOWL
Regulation Number 880.5200
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2017 2 2
2019 2 2
2020 4 4
2021 4 4
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7 7
Retraction Problem 2 2
Crack 2 2
Bent 1 1
Break 1 1
Defective Device 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Patient Device Interaction Problem 1 1
Leak/Splash 1 1
Misconnection 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6 6
No Known Impact Or Consequence To Patient 4 4
No Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Code Available 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Access Scientific LLC III Jul-10-2020
2 Medical Action Industries, Inc. 306 II Dec-08-2022
3 Stradis Healthcare II Jan-11-2023
4 Vygon U.S.A. II May-04-2018
-
-