Initial reporter e-mail: unknown.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1152440.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
|
It was reported that the bd posiflush¿ normal saline syringe end of the plunger rod was found damaged during use.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the infusion of the patient was completed.When sealing the picc of the patient, the nurse found that the tail of the core rod of the 10ml flush was incomplete, and the injection could not be pushed.After communication with the nurse, the patient expressed understanding and replaced the 10ml catheter flusher with the sealing tube.".
|