Duraseal sealant system (202050) was not returned for analysis after three good faith attempts (gfes) and the investigation could not confirm the complaint.As a result, the root cause of the reported issue could not be determined.However, lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Per the fmea, potential causes of failure include: performance [swelling], biocompatibility, performance [packaging integrity], sterilization [system], and sterilization the risk remains acceptable per the risk analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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A distributor reported that during an unspecified surgery, duraseal dural sealant system 5ml us box of 5 (202050) was retrieved from cold shelter for use at the completion of the surgery.The surgical consultant who attended the surgery reported that when he put the syringe in the vial, it began to spill over the sides and the product could not be used - "it was like it didn't fit right." it was necessary to open a new one since it was required for the surgery.There was no patient injury or surgical delay.
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