Sedaconda Syringe

The Sedaconda Syringe is a 50/60ml syringe with a unique connection to fit the connector on the agent line of the Sedaconda ACD and Sedana Medical filling adapters. It should only be used with CE marked syringe pumps which are programmable with settings for Sherwood Monoject or Becton Dickinson Plastipak 50ml (50/60ml) syringes. Syringes can be pre-filled and stored for up to 5 days in a dark environment at room temperature. Always ensure the syringe is safely closed when not in use.

Use: Single usage
Device Classification: Class IIa
Shelf Life: 5 Years from Date of Manufacturing
Reference Number: 1026022
Disposal: according to hospital protocol
Packaging unit: 1 unit contains 25 Sedaconda Syringes

Tech Specs
IFU
Accessories
Field Safety Notice

Technical Specifications

Intended use

To be used in conjunction with Sedaconda ACD-S and Sedaconda ACD-L. Ref: 1026100 / 1026050

Please refer to “Instructions for Use” for more information.

Anaesthetic agents:	isoflurane or sevoflurane
Filling Volume:	50 ml
Storage Time for filled syringe:	Up to 5 days in a dark area at room temperature

The product IFU can be printed directly from the weblink provided. Alternatively, a copy can be provided on request by emailing info@sedanamedical.com
Instruction for Use (IFU), Rev.2
Superseded_Instruction for Use (IFU), Rev.1

A potential issue related to the connection interface between the Sedaconda Syringe and agent line was identified, which could lead to product leakage and suboptimal performance. The root cause was traced to dimensional variations affecting component fit.

Corrective actions were implemented, including updates to the Instructions for Use, revised training materials, and direct customer communication. In addition, the manufacturing process was improved by replacing manual testing with 100% automated leak testing to enhance quality control.

All affected customers were informed, and implementation of the updated instructions has been confirmed. No adverse events or patient harm have been reported. No further complaints have been received following the implementation of corrective measures, and the issue is considered resolved.

Sedaconda Syringe