FDA
Rocket KCH Fetal Bladder Drainage Catheter
Model: R57405
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
Rocket Medical issued Urgent Field Safety Notice (FSN) dated July 30, 2019 advising of problem, action taken: update to IFU-Do NOT pull the tip of the catheter in an attempt to straighten it as this will induce twisting of the material and cause the catheter to kink. In addition added :This product is contraindicated for pleural drainage. Communicate this FSN to Hospital Supply Departments, Medical Device Safety Officers and those working within fetal medicine within your facility. For any devices that have been transferred to other organization(s), please ensure that details of these devices are returned to Rocket Medical and that a copy of the FSN is provided to the organization(s) to which the device has been transferred. Complete, scan and return response form, or email your responses, as soon as possible but before August 31st to cust-occ110@rocketmedical.com.