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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
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 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
2021 4 4
2023 6 6
2024 2 2
2025 1 1
2026 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 11 11
Material Twisted/Bent 9 9
Physical Resistance/Sticking 7 7
Insufficient Device Problem Information 6 6
Detachment of Device or Device Component 6 6
Material Separation 6 6
Unraveled Material 5 5
Deformation Due to Compressive Stress 4 4
Material Frayed 3 3
Fracture 3 3
Difficult to Remove 3 3
Device Damaged Prior to Use 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Difficult to Advance 1 1
Patient Device Interaction Problem 1 1
Leak/Splash 1 1
Imprecise or Erratic Results 1 1
Entrapment of Device 1 1
Difficult to Open or Close 1 1
Blocked Connection 1 1
Material Rupture 1 1
Material Puncture/Hole 1 1
Obstruction of Flow 1 1
Difficult to Flush 1 1
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 15 15
Foreign Body In Patient 3 3
Hemorrhage/Blood Loss/Bleeding 2 2
Extravasation 1 1
Device Embedded In Tissue or Plaque 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 1 1
Failure of Implant 1 1
Blister 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 ARROW INTERNATIONAL, LLC II Apr-22-2026
3 LSL Healthcare Inc. II Jan-29-2026
4 Medical Action Industries, Inc. 306 II Dec-08-2022
5 Stradis Healthcare II Jan-11-2023
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