Procedure: thoracotomy with left upper lobectomy.Cathplace: left anterior chest.It was reported that a catheter broke under a patient's skin.It was reported as, "according to staff, patient was receiving pain management therapy via an on-q pain ball with catheter in the left lateral back and left anterior chest sites.During assessment of patient, rn noted that the left anterior catheter was broken.Notified pa who removed subcutaneous catheter, observed small piece of catheter was left under the skin.Physician and on-q pain rep notified".It was reported that the device is available for return and analysis.Additional info was requested, however, is not available at this time.
|
Method: the device was reported to be returning for an evaluation and at this time is pending return.The lot number provided 0200989916 belongs to an on-q pump which does not include a catheter, therefore for the lot number and model number are unk at this time.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a f/u report will be submitted.A copy of the medwatch form number 18004-199-2014-0006 is attached.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.
|