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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
2019 2 2
2020 4 4
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4 4
Material Puncture/Hole 1 1
Defective Device 1 1
Break 1 1
Crack 1 1
Contamination /Decontamination Problem 1 1
Leak/Splash 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 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
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