CONTIPLEX

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE AND/OR LOT NUMBER. WITHOUT THE ACTUAL DEVICE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: COMPLAINT: ANESTHESIOLOGIST STATED THAT APPROXIMATELY 3 CM OF A POLYAMIDE CATHETER TIP REMAINED IN PATIENT AFTER PLACEMENT OF A CONTINUOUS PERIPHERAL NERVE BLOCK (ADDUCTOR BLOCK). ANESTHESIOLOGIST STATED SHE FELT SOME RESISTANCE DURING PLACEMENT OF NEEDLE AND CATHETER. IT FELT LIKE THE CATHETER WAS "STUCK IN THE NEEDLE" AND UPON REMOVAL OF THE NEEDLE AND CATHETER, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD "SHEARED" OFF. ANESTHESIOLOGIST WAS CONCERNED ABOUT THE BROKEN TIP THAT REMAINED IN THE PATIENT AS THE PATIENT WAS CURRENTLY IN THE OPERATING ROOM FOR SURGERY. NO RECOMMENDATION WAS GIVEN. CUSTOMER WAS PROVIDED WITH TYPE OF CATHETER - POLYAMIDE AND INFORMED THE CATHETER IS BIOCOMPATIBLE. INJURY - BROKEN TIP OF CATHETER REMAINED IN PATIENT.