(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "clinicians must be aware of complications/undesirable sideeffects associated with this device inclu ding, but not limited to.Extravasation.Warning: to reduce the risk of possible vessel wall perforation, do not leave tissue dilator in place as an indwelling catheter." a device history record review was performed based on a potential lot from sales history and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: event date changed to 07/14/2023 after receipt of additional information.Codes added for scar and another device needed.Additional information informed us that the patient was deceased.Time interval between the complaint issue and death was 12 days.Cause of death was respiratory failure.It was stated that the death was not caused by the incident.
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