A.2.Patient¿s birthday was not provided, (b)(6) 2023 was used based on age of patient.H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3047973.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.
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It was reported while using bd posiflush¿ normal saline syringes there were plunger difficulties.There was no report of patient impact.The following information was provided by the initial reporter: describe the event or problem: the flush was clogged.The nurses thought it was an iv infiltrate and pulled the iv, when it was a clogged saline flush and not the iv itself.What was the original intended procedure? : to give a medication and provide a flush after the medication administration.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ;.
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