H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 2040574.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.
|
It was reported while using bd pre-filled normal saline syringe there was a crack that led to leakage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: at 8 am on (b)(6) 2023, when it followed the doctor's instructions for intravenous infusion for the child, when it was about to open the pre-flush tube of the flush, it found that the flush leaked, had cracks, and could not be used normally.Replace it with a new one immediately catheter irrigator, no patient harm.
|