| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00587-1 |
| Product Name/Description |
Plastipak 50ml Syringes
Product code: 300865
All Lot Numbers Within Expiry
ARTG 326821
(Becton Dickinson Pty Ltd - Syringe, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/04/2022 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson advise they have received two (2) complaints reporting an observation of air in damaged syringes for BD Pastipak 50ml Syringe with Luer-Lok Tip. The first complaint involved a patient with a gas embolism with the origin of the gas embolism still under investigation. The second complaint was a damaged syringe connected to a pump that was identified before air was injected so there were no adverse health consequences.
When a damaged barrel syringe is used with a syringe pump, there is a possibility that ingress of air into the syringe could potentially inject air into the vascular system. Also, a flow rate fluctuation may occur altering the flow of medications within the syringe. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Becton Dickinson ask customers to
1. Follow good clinical practice regarding the inspection of medical devices for damage before, during and after use.
2. If damaged syringes are identified report the defect to BD.
3. Communicate this Product Defect Correction with appropriate members of their facility.
4. Complete the attached Acknowledgement Form and email to BD at ANZ_Quality@bd.com if they have the impacted medical device or not.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
This action has been closed out on 13/12/2023 |
| Contact Information |
ANZ_Quality@bd.com |