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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device piston syringe with neuraxial connector – epidural, peripheral, and/or indirect cerebral spinal fluid contact
Definition A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Product CodeQEH
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTIGLASS SRL
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3 3
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Bradycardia 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Retention 1 1

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