(b)(4).Investigation summary: a device history record review was completed for provided material number 30654778 and lot number 0218163.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, five physical samples were received for evaluation by our quality team.The samples came with no packaging flow wrap and no tip cap.A visual inspection was performed and no defects or imperfections were observed.Each sample was then tested for sustaining force and all results were within specification.Based on the investigation results, the sample received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.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.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.Probable root cause is unknown, the samples were within specification.
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It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: material no.: 306547 batch no.: 0218163.We have seen an uptick in issues the last week and we originally thought it was the needless connector but now know it¿s the flush.I have like 4 syringes kept for me (originally because i wanted to see what was occurring) luckily no harm to patients or issue with ivs, we just thought the iv that was good suddenly stopped working and realized it was the flush¿.They flush until the 6ml point and then they ¿lock up¿ and don¿t flush.It¿s really weird.It¿s really hard to flush- like it gets hung up on something? i have about 4 here, but no patient info.Just the syringes with 2-4ml left in them from us trying to force them to flush.
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