H10: manufacturing review: a complaint history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: one truguide coaxial needle was returned with two labels and three sealed lot samples.No anomalies were noted to the lot samples provided.Two electronic photos were also provided for review.The hub of the original truguide sample was returned attached to a three-way valve.A visual inspection of the original device as well as the photo review confirmed that the hub and cannula needle had separated.As such, the investigation is confirmed for the reported break.Per the reported event details and based on the evaluation results, a three-way valve of unknown origin was attached to the truguide hub during the procedure to aspirate air during the procedure.As such, it is possible that conditions of use contributed to the reported break.However, the definitive root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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