Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1152083.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.Our quality team regularly reviews the collected data for identification of emerging trends.
|
It was reported when using the bd posiflush¿ syringe, the user identified a damaged / deformed broke product.The following information was provided by the initial reporter.The customer stated: when sealing the tube for the patient, the nurse found that the flush broke and could not be used normally, so it was replaced immediately.
|