It was reported that the cap was found separated from the bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: when flushing the 8-bed patient picc, the cap of the flush was found to have fallen off (the outer packaging was not opened).
|
Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1202737.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.With no sample analysis, a probable root cause could not be offered.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.
|