[19140707]
Recent chest x-ray shows fracture of the catheter in the subclavian vein from the last surgery a year ago. Patient was admitted to the surgery again for removal of this broken catheter. Under iv sedation, a small incision was made over the catheter just beneath the clavicle. The catheter was withdrawn, and it was noted that the fracture distal tip, approx. 3cm, remained in the subclavian vein without dislodgement. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: a device from same lot was evaluated, visual examination. Results of evaluation: other. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5