|
B5: additional information.Investigation evaluation: visual examination and functional testing of the returned product was performed.Additionally, a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data and specifications was conducted.One device and 1 ml syringe was returned for investigation.Using the returned syringe, a functional test determined the balloon did not inflate.An attempt was made to inflate the balloon with water.A visual examination noted the returned syringe has cracks allowing fluid to leak and the balloon did not to inflate.The returned syringe was damaged.Using a stock 1 ml syringe, the balloon inflated and deflated properly with water.The device functioned as intended when a stock syringe was used.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.The device history record was reviewed and one non-conformance issue was identified for failed the leak test.The issue was related to a damaged fitting and the item was reworked.A review of complaints involving this device lot revealed this complaint is the only complaint that has been received associated with complaint device lot number 7482501.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally for leaking and inflation during manufacturing and no notable gaps in production or processing controls were noted.A review of the instructions for use (ifu) noted a warning against using air to inflate the balloon.The reporter indicated the device was inflated with air.Air is non-sterile and since the j-chsg is designed to be used with sterile water, this could have caused or contributed to the reported deflation difficulty.One of the devices and a syringe were returned and a crack was observed in the syringe.Although this could cause the difficulties with deflation, it is unknown if a similar crack affected the two related balloons.It is unknown if this also impacted the unreturned units or if the cracked syringe may have happened after its use, as it was reported the balloons were able to be inflated initially.It can also be noted that it was reported the balloon was inflated with air instead of sterile water.Once a known good syringe was used during testing and water was used to inflate the balloon, the device performed normally.Based on the information provided, a definitive root cause could not be determined.Measures have been initiated to address this issue of inflation/deflation difficulties.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
