Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1105735.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
|
It was reported when using the bd posiflush¿ syringe there was leakage.The following information was provided by the initial reporter.The customer stated: "when puncturing the patient with an infusion indwelling needle, the tube failed to be sealed during the flushing process, and the prefilled liquid leaked out.".
|