Initial reporter e-mail: unknown.Investigation summary: in response to the event reported, a device history review was conducted for lot number 1287029.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
|
It was reported that the bd intima ii¿ iv catheter prn adapter unit packaging was found damaged before use.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the patient wanted to use a closed vein indwelling needle for infusion.Before infusion, the outer packaging of the indwelling needle was found to be damaged.The needle was immediately discarded and replaced with a new qualified closed vein indwelling needle.".
|