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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone marrow collection/transfusion 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 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 CodeLWE
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 3 3
2021 8 8
2022 6 6
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 9 9
Packaging Problem 5 5
Delivered as Unsterile Product 3 3
Break 2 2
Contamination 1 1
Disconnection 1 1
Gradient Increase 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Needle Stick/Puncture 7 7
No Consequences Or Impact To Patient 6 6
No Patient Involvement 3 3
Pseudoaneurysm 1 1
Abrasion 1 1
Abscess 1 1

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