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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lumbar puncture tray (adult & pediatric)
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 CodePWY
Regulation Number 880.5570
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1
2021 35 35
2022 6 6
2023 9 9
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 16 16
Fluid/Blood Leak 16 16
Complete Blockage 4 4
Defective Device 4 4
Contamination 3 3
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Activation, Positioning or Separation Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 15 15
Needle Stick/Puncture 5 5
Cerebrospinal Fluid Leakage 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Mar-16-2022
2 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Feb-07-2018
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