Medical device manufacturer, Smiths Medical, has issued a medical device safety alert concerning its GRIPPER Non-Coring Safety Needle, PORT-A-CATH system:
The manufacturer performed an analysis to address a perceived increase in the complaints for GRIPPER products. The complaint data exhibited an increase of occluded products manufactured after the installation of new manufacturing equipment and a reduction in the inspection for the patency test from 100% to a sampling plan.
According to the manufacturer, they received a total of 156 complaints for the lots manufactured from 1 June 2018 through 21 February 2019.This is the interval where the sampling was reduced for the patency test from 100% to a sampling plan. If an occlusion in the GRIPPER needle is noted, it will need to be replaced to allow the infusion procedure to move forward. This may lead to a delay in therapy but not an interruption of therapy.
The GRIPPER needle will be assessed for patency at multiple steps prior to use on the patient to gain access to the PORT-A-CATH implanted catheter system. If the needle is occluded, the needle will be replaced with a patent needle prior to moving forward with the procedure. A needle can be evaluated for occlusion as the infusion system, e.g. syringe, extension set and GRIPPER needle, or as an individual component. The system will be fully primed to remove air and the needle's patency will be evaluated. Multiple replacement GRIPPER needles are typically readily available to clinicians. The hazardous situation is readily detectable in the normal clinical flow in the use of the GRIPPER needle and easily mitigated with product on-hand.
According to the manufacturer, the sampling plan was returned to 100% inspection for the patency test in the manufacturing process.
Product recall is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 9 July 2019