The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-may-2023.H6: investigation summary: a device history record review was completed for provided material number 309110 and lot number 2210152.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, four (4) sample units were returned for evaluation.However, through inspection of the samples, no signs of defect were observed.The provided samples did not display any functionality issue.The medication used or a special method of handling (high temperatures, pressures, several uses, etc.) could affect the functionality of the syringe.At this time, an exact cause could not be identified.
|