Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
|
The following fields were updated due to additional information: concomitant medical products: device available for eval yes.Returned to manufacturer on: 2021-03-19.H6: investigation summary: one infusion bag connected to a c90 connector along with one syringe connected to a injector were returned to our quality team for investigation.The product was visually inspected, no defects or damage observed on the membranes of either device, the spike of the connector, or needle of the injector.During our evaluation, a black foreign particle was observed inside the syringe.Given the small size of the particle, characterization testing was not able to identify the composition.Qualitive testing of the elements using x-ray was performed and found the particle consisted mainly of iron, a material that is not verified to be in the phaseal components.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.Based on sample investigation, it does not appear as though the particle originated from the phaseal devices; therefore we cannot identify a root cause at this time.H3 other text : see h10.
|