| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00335-1 |
| Product Name/Description |
BD Vacutainer Multiple Sample Luer Adapter
Ref. No.: 367300
All lot numbers manufactured starting with lot number 1354918 and after
ARTG: 122153 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
BD has received a number of following complaints relating to blood leakage when the Vacutainer Adapter is used in the blood collection process:
1)The sleeve covering the NP cannula - non-sleeve recovery, sleeve leakage, and sleeve fall off (pop-off). Should such an event occur, there is an increased likelihood of blood leakage into the tube holder when a blood collection tube is removed from the tube holder (i.e. the sleeve fails to re-cover the NP cannula allowing blood to leak into the tube holder). BD estimates that approximately 1.47% of the devices will be impacted by this issue.
2)Luer tip damage – small “nicks” or “flash” have been observed on the luer tip that connects to needles, blood collection sets, and infusion sets. Should such a damaged device be used, there is an increased likelihood of blood leakage from the connection between the Vacutainer Adapter r and the access device. BD estimates that less than 1% of the devices will be impacted by this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
BD is requesting customers to consider the risk of using a defective device in relation to their ability to maintain necessary blood collection procedures without the use of the BD Vacutainer Multiple Sample Luer Adapter. Should the customers choose to continue using the BD Vacutainer Multiple Sample Luer Adapter, BD is asking to ensure that all relevant staff are aware of the potential defects. BD also recommends that staff closely observe the luer tip of the device for potential damage. In the event that damage is observed, please instruct staff to discard the individual device. Should blood leak from the luer connection during blood collection please assess the need to conduct a re-draw, with a new luer adaptor, based upon the volume of blood within the tube (i.e. a low volume draw would require a re-draw). This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 656 100 - BD Customer Service Department |