[1663]
Catheter was inserted supra-pubicly and bulb inflated with 7 cc. For glycine irrigation during turp. Abdominal distention noted at end of procedure. Flexible cysto performed and under direct vision of the bladder the hole where the suprapubic catheter had been was see, documenting that the suprapubic catheter had slipped out of the urinary bladder. The suprapubic catheter was removed and it was noted that the balloon had a hole in it and was deflated. The patient was admitted to icu for observation, diuresis, and iv antibiotic therapy with discharge home 3 days later. The catheter in question has been retained and the only additional catheter with the same lot number has been removed from stock. The only other medical device in place at the time was a foley catheter inserted without use of any guide. 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, a device from same lot was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: device failure occurred and was related to event, device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5