Fill volume: unknown.Flow rate: unknown.Procedure: myomectomy.Cathplace: under the fascia and in the subcutaneous layer.A report was received stating in (b)(6) 2015 there were two catheter break incidents in which a dual on-q pump was used.One catheter was successfully removed and the other broke inside of the patient.Additional information received 13-jul-2016 stated initially the bupivacaine pain catheter was sutured "under the fascia and in the subcutaneous layer." on (b)(6) 2015 the patient was admitted for infection and cellulitis due to retained catheter.On (b)(6) 2015 it was later discovered by the physician that the catheter was sutured to the fascia layer instead and thus was unable to be remove.On (b)(6) 2016 a surgical wound exploration was required for removal of retained catheter.On 21-jul-2016 additional information from the physician stated the product was not an issue.The issue was due to user error.In addition, the patient was more susceptible to infection because she suffers from an autoimmune disease.No additional information was provided.
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