[17178599]
Epidural catheter placed for pain control while patient in labor. On removal of the epidural catheter the tip was noted as missing. Spinal x-rays obtained. Unable to locate catheter tip radiologically. No special treatment rendered. Patient did not exerience any untoward affects. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, none or unknown, unanticipated. Conclusion: device failed just prior to use, device failure directly caused event, device failure directly contributed to event, device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5