| TGA Action ID |
RC-2024-RN-00914-1 |
| Type of Product |
Medicine |
| Product Name/Description |
ADRENALINE-LINK 1:10 000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre-filled syringe
Product code: 100339
Batch number: 0148888
ARTG 210672 |
| ARTG Number |
210672 |
| Action Type |
Product Defect Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Reports of blocked ADRENALINE-LINK 1:10,0001mg/10mL adrenaline epinephrine) acid tartrate injection BP prefilled syringe bores have been received by the Therapeutic Goods Administration (TGA) and LINK, which have made it difficult or impossible to administer this product in an emergency.
LINK also advises that not all connector systems are directly compatible with ADRENALINE-LINK pre-filled syringes (PFS) resulting in serious risk to patient safety.
A blocked syringe or use of an incompatible connector may result in the required dose not being administered to patients in emergency situations such as the management of cardiac arrest or emergency treatment of acute anaphylactic reactions.
There has been reported deaths associated with the blocked syringe problem.
The manufacturer is still investigating the cause of the blocked syringes.
|
| Instructions for Customers/Users |
The manufacturer is still investigating the blocked syringe problem and customers will be notified when further information is available.
Health Care Facilities are to:
- be aware of the serious defects and if possible have a backup syringe available.
- Note that not all connector systems are directly compatible with ADRENALINE-LINK pre-filled syringes (PFS). An updated list of compatible connectors and adaptor systems is provided in the customer letter.
- The list of compatible syringes is to be co-located with the product.
- Attach a compatible connector to the product to ensure a compatible connector is used.
Distributors are to follow the instructions in the customer letter which includes forwarding the customer letter immediately to all affected customers.
This action has been superseded by RC-2026-RN-00267-1.
This action has been closed out on 04/06/2026 |
| Action Commencement Date |
17/10/2024 |
| Responsible Entity |
|
| Contact Information |
1800 181 060 - LINK Customer Service |