Bd received samples from the customer facility for investigation.A visual/microscopic examination revealed that the edges of the remaining catheter tubing were smooth, with the exception of a small portion which exhibited roughness and jaggedness.The customer's experience was confirmed by the returned unit.The reported defect was not created during the manufacturing process.Had this damage occurred to the device prior to insertion into the patient's vasculature, the device would not have been successfully inserted as reported in the customer's verbatim description.Furthermore, the device would not have performed under power injection, which was reported as successful and without incident in the verbatim description.Bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.The reported defect did not occur as a result of the manufacturing process or design of the product.
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