Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Therefore, the reported leak at the connection and unable to aspirate issue cannot be confirmed.A definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 05/2021).
|
It was reported that during a catheter placement procedure, there was allegedly a leak at the end of the puncture needle.It was further reported that, device was not tightly connected with the syringe and as a result, the device could not be aspirated.The procedure was completed using another device.There was no reported patient injury.
|