Investigation summary: one photo was provided.It shows a syringe connected to a port and it has blood in it.The plunger rod shows a gap with the rubber stopper however it is not fully separated.Failure mode is verified however root cause cannot be determined based on the photo.Please note that the posiflush product is designed to flush the lines, not for drawing blood.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for the lot# 9018574 for the same defect or symptom.There was no documentation of issues for the complaint of batch 9018574 during the production run.Root cause description: undetermined.
|
It was reported that bd posiflush¿ normal saline syringe plunger separated during use.The following information was provided by the initial reporter: material no.: 306547, batch no.: 9018574.It was reported that the plunger of the ns flush syringe became disconnected from the black seal.We encountered an issue with one of our ns flushes this afternoon.While drawing back blood from a port via a stop-cock, the plunger of the ns flush became disconnected from the black seal.We realized after grabbing new supplies, that it was just a matter of screwing it back into place.One of float nurses from the picu told us this is a known issue for them lately and it sounds like this has happened a few times as well.Just wanted to make sure you are aware of this.It might be helpful to give our nurses a heads up.We did not keep the syringe since it had blood in it, but here is a photo with the lot# just in case you need it.
|