Featured HeartNet Report of Interest
MedSun: Newsletter #53, October 2010

Your reports of actual adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and HeartNet. The following event reported by a MedSun facility resulted in manufacturer action:

Type of Device: angiographic syringe
Device Brand Name: Stellant CT Dual Syringe Kit
Device Manufacturer’s Name: MedRad
Date of this report: April 15, 2010
Other device identifiers: SDS-CTP-QFT

Reported Event:
Multiple problems with tubing not adhering to connectors and t-connectors cracking. For example, in one case the connector will separate from the tubing. In another case the connector hub is cracking when used. This has happened multiple times recently, but 4 times within 24 hours where the product has been saved. We have retained 6 defective sets from two lot numbers. MedRad says they are aware of the problem and will provide replacement tubing. MedRad declined to tell me what lot numbers were affected. This is not a new product for the facility. In most cases this occurred while setting up the injection. No harm to patients, but technicians are concerned that a fragment of the connector could fall into the contrast. In one case they were not sure so they discarded the contrast and started over.
==================
Health professional's impression
==================
defective product.

Related Recall: Please see the following Class 2 recall for Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK manufactured by MedRad. The reason for the recall is due to kits containing a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92193

Additional Information:

Class 2 Recall - Stellant CT Dual Syringe Kits. July 9, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92193


MedSun Newsletters are available at www.fda.gov/cdrh/medsun