Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1085203.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.
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It was reported when using the bd posiflush¿ normal saline syringe there was difficult plunger movement.The following information was provided by the initial reporter.The customer stated: "after the patient's infusion, the nurse sealed the tube with a flush.After injecting about 5ml of liquid, she suddenly felt that there was resistance to pushing the core rod.The piston could not be pulled back, and immediately replaced with another one.After about 4ml of liquid was injected successfully, the stopper could not be pushed.".
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